<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672892</url>
  </required_header>
  <id_info>
    <org_study_id>RTOG-1203</org_study_id>
    <secondary_id>CDR0000738944</secondary_id>
    <secondary_id>NCI-2012-02001</secondary_id>
    <nct_id>NCT01672892</nct_id>
  </id_info>
  <brief_title>Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer</brief_title>
  <official_title>A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radiation Therapy Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>NRG Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radiation Therapy Oncology Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill&#xD;
      tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to&#xD;
      the tumor may kill more tumor cells and cause less damage to normal tissue.&#xD;
&#xD;
      PURPOSE: This randomized phase III trial is studying two different methods of radiation and&#xD;
      their side effects and comparing how well they work in treating endometrial and cervical&#xD;
      cancer after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      Primary&#xD;
&#xD;
        -  To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute&#xD;
           gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as&#xD;
           measured with the expanded prostate cancer index composite (EPIC) instrument.&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for&#xD;
           Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional&#xD;
           whole-pelvis radiation therapy (WPRT).&#xD;
&#xD;
        -  To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT&#xD;
           compared to conventional WPRT.&#xD;
&#xD;
        -  To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain.&#xD;
&#xD;
        -  To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic&#xD;
           radiation treatment or four-field pelvic radiation treatment for endometrial or cervical&#xD;
           cancer.&#xD;
&#xD;
        -  To assess the impact of pelvic IMRT on quality of life using the Functional Assessment&#xD;
           of Cancer Therapy-General (FACT-G) with cervix subscale.&#xD;
&#xD;
        -  To determine if there is any difference in local-regional control, disease-free&#xD;
           survival, and overall survival between patients treated with IMRT as compared to&#xD;
           conventional WPRT.&#xD;
&#xD;
        -  To perform a health-utilities analysis to measure the financial impact of pelvic IMRT&#xD;
           via the EQ-5D instrument.&#xD;
&#xD;
        -  To identify molecular predictors of radiation toxicity and novel circulating cancer&#xD;
           biomarkers.&#xD;
&#xD;
      OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer&#xD;
      (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²),&#xD;
      and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
        -  Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up&#xD;
           to 5-6 weeks.&#xD;
&#xD;
        -  Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for&#xD;
           up to 5-6 weeks.&#xD;
&#xD;
      Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5&#xD;
      weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or&#xD;
      disease progression.&#xD;
&#xD;
      Tissue and blood samples may be collected for biomarker and correlative analysis.&#xD;
&#xD;
      Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer&#xD;
      Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version&#xD;
      4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome&#xD;
      [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.&#xD;
&#xD;
      After completion of study therapy, patients are followed every 6 months for the first 2 years&#xD;
      and then annually for 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 20, 2022</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation</measure>
    <time_frame>Baseline and week 5 of RT</time_frame>
    <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment</measure>
    <time_frame>Baseline to Week 5 of RT</time_frame>
    <description>Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Toxicity, as Measured by Change in EPIC Urinary Domain</measure>
    <time_frame>Baseline, week 3 and 5 of RT, and 4-6 weeks after RT</time_frame>
    <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale</measure>
    <time_frame>Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT</time_frame>
    <description>The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires &gt;= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utilities, as Measured by Change From Baseline in EQ-5D</measure>
    <time_frame>Baseline, week 5 of RT, 4-6 weeks after RT</time_frame>
    <description>The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local-regional Recurrence</measure>
    <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
    <description>Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
    <description>Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
    <description>Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers</measure>
    <time_frame>Outcome measure will not be analyzed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)</measure>
    <time_frame>Baseline and week 5 of RT</time_frame>
    <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)</measure>
    <time_frame>Baseline and week 5 of RT</time_frame>
    <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)</measure>
    <time_frame>Baseline and week 5 of RT</time_frame>
    <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)</measure>
    <time_frame>Baseline and week 5 of RT</time_frame>
    <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.&#xD;
A positive change score represents a decline in function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">289</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Endometrial Cancer</condition>
  <condition>Gastrointestinal Complications</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <condition>Radiation Toxicity</condition>
  <condition>Urinary Complications</condition>
  <condition>Urinary Tract Toxicity</condition>
  <arm_group>
    <arm_group_label>Intensity-Modulated Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Radiation Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard radiation therapy</intervention_name>
    <description>Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.</description>
    <arm_group_label>Intensity-Modulated Radiation Therapy</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>intensity-modulated radiation therapy</intervention_name>
    <description>Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.</description>
    <arm_group_label>Standard Radiation Therapy</arm_group_label>
    <other_name>IMRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Pathologically proven diagnosis of endometrial or cervical cancer.&#xD;
&#xD;
          2. Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal&#xD;
             hysterectomy or radical hysterectomy or total laparoscopic hysterectomy) for carcinoma&#xD;
             of the cervix or endometrium within 49 days prior to registration. Performance of a&#xD;
             bilateral salpingooophorectomy will be at the treating surgeon's discretion.&#xD;
&#xD;
          3. Appropriate stage for protocol entry, including no distant metastases, based upon the&#xD;
             following minimum diagnostic workup:&#xD;
&#xD;
               -  3.1 History/physical examination within 45 days prior to registration;&#xD;
&#xD;
               -  3.2 CT, MRI or positron emission tomography - computed tomography (PET-CT)&#xD;
                  including the abdomen and pelvis should be performed for initial radiological&#xD;
                  staging. This may be performed pre- or post-surgery within 90 days prior to&#xD;
                  registration. Imaging performed post-operatively should show no evidence of&#xD;
                  residual disease. Any evidence of malignancy identified on pre-operative imaging&#xD;
                  should have been completely resected surgically prior to protocol treatment.&#xD;
&#xD;
               -  3.3 Chest CT or chest x-ray must be performed within 90 days prior to&#xD;
                  registration (unless a PET-CT has been performed)&#xD;
&#xD;
          4. Zubrod Performance Status 0-2&#xD;
&#xD;
          5. Age ≥ 18;&#xD;
&#xD;
          6. Complete blood count (CBC)/differential obtained within 14 days prior to registration&#xD;
             on study, with adequate bone marrow function defined as follows:&#xD;
&#xD;
               -  6.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;&#xD;
&#xD;
               -  6.2 Platelets ≥ 100,000 cells/mm3;&#xD;
&#xD;
               -  6.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to&#xD;
                  achieve Hgb ≥ 8.0 g/dl is acceptable.)&#xD;
&#xD;
          7. For patients receiving chemotherapy:&#xD;
&#xD;
        7.1 Within 14 days prior to registration, serum creatinine ≤ 1.5 mg/dL and calculated&#xD;
        creatinine clearance ≥ 50 cc/min. Both tests must be within these limits. The creatinine&#xD;
        clearance should be calculated using the Cockcroft-Gault formula: (See Section 7.3.1) 7.2&#xD;
        Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) 7.3 Bilirubin ≤ 2 x ULN&#xD;
        7.4 Alkaline phosphatase, Mg, blood urea nitrogen (BUN) and electrolytes must be obtained&#xD;
        and recorded 8 Endometrial Cancer: 8.1 Patients with the following histologic features are&#xD;
        eligible for pelvic radiation therapy without weekly cisplatin:&#xD;
&#xD;
          -  &lt;50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma&#xD;
             (USC) or clear cell histology&#xD;
&#xD;
          -  ≥50% myometrial invasion grade 1-2 adenocarcinoma without USC or clear cell histology&#xD;
             8.2 Patients with the following histologic features may be treated with pelvic&#xD;
             radiation with or without weekly cisplatin. The decision to add weekly cisplatin for&#xD;
             these patients is at the treating physician's discretion:&#xD;
&#xD;
          -  ≥50% myometrial invasion, grade 3 including USC and clear cell carcinoma.&#xD;
&#xD;
          -  International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial&#xD;
             cancer of any grade including USC and clear cell carcinoma.&#xD;
&#xD;
          -  FIGO 2009 IIIC1 (pelvic lymph node positive only, para-aortic nodes negative if&#xD;
             removed) including USC and clear cell carcinoma. Note: If para-aortic nodes are not&#xD;
             removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy. 9.&#xD;
             Cervical Cancer: 9.1 Patients with the following pathology findings may be treated&#xD;
             with pelvic radiation with or without weekly cisplatin at the treating physician's&#xD;
             discretion. The decision to add weekly cisplatin for these patients is at the treating&#xD;
             physician's discretion. 9.1.1 Patients with intermediate risk features including two&#xD;
             of the following histologic findings after radical hysterectomy:&#xD;
&#xD;
          -  1/3 or more stromal invasion&#xD;
&#xD;
          -  Lymph-vascular space invasion&#xD;
&#xD;
          -  Large clinical tumor diameter (&gt; 4 cm) 9.1.2 Patients with cervical cancer treated&#xD;
             with a simple hysterectomy with negative margins 9.2 Patients with any of the&#xD;
             following criteria following radical hysterectomy are eligible for this study and must&#xD;
             receive weekly cisplatin:&#xD;
&#xD;
          -  Positive resected pelvic nodes and para-aortic nodes negative if removed. Note: If&#xD;
             para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence&#xD;
             of lymphadenopathy.&#xD;
&#xD;
          -  Microscopic parametrial invasion with negative margins. 10. Patient must provide study&#xD;
             specific informed consent prior to study entry. 11. Willingness and ability to&#xD;
             complete the bowel and urinary domains of the EPIC prior to registration&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients with para-aortic nodal disease or who require extended field radiotherapy&#xD;
             beyond the pelvis.&#xD;
&#xD;
          2. Patients with histology consisting of endometrial stromal sarcoma, leiomyosarcoma or&#xD;
             malignant mixed mullerian mixed tumor (MMMT or carcinosarcoma)&#xD;
&#xD;
          3. Patients who exceed the weight/size limits of the treatment table or CT scanner.&#xD;
&#xD;
          4. Mental status changes or bladder control problems that make the patient unable to&#xD;
             comply with bladder-filling instructions.&#xD;
&#xD;
          5. Patients with evidence of metastatic disease outside of the pelvis.&#xD;
&#xD;
          6. Patients with positive or close (&lt; 3 mm) resection margins&#xD;
&#xD;
          7. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free&#xD;
             for a minimum of 3 years.&#xD;
&#xD;
          8. Prior radiation therapy to the pelvis&#xD;
&#xD;
          9. Patients with active inflammatory bowel disease. 10 Severe, active co-morbidity,&#xD;
             defined as follows:&#xD;
&#xD;
               -  10.1 Unstable angina and/or congestive heart failure requiring hospitalization&#xD;
                  within the last 6 months&#xD;
&#xD;
               -  10.2 Transmural myocardial infarction within the last 6 months&#xD;
&#xD;
               -  10.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the&#xD;
                  time of registration&#xD;
&#xD;
               -  10.4 Other major medical illness which requires hospitalization or precludes&#xD;
                  study therapy at the time of registration&#xD;
&#xD;
               -  10.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation&#xD;
                  defects; note, however,that laboratory test coagulation parameters are not&#xD;
                  required for entry into this protocol&#xD;
&#xD;
               -  10.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for&#xD;
                  Disease Control and Prevention (CDC) definition; note, however, that HIV testing&#xD;
                  is not required for entry into this protocol. The need to exclude patients with&#xD;
                  AIDS from this protocol is necessary because the treatments involved in this&#xD;
                  protocol may be significantly immunosuppressive. Protocol-specific requirements&#xD;
                  may also exclude immunocompromised patients.&#xD;
&#xD;
        11. Patients with prior treatment with platinum-based chemotherapy 12. Women who are&#xD;
        breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann Klopp, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology-Deer Valley Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Services Foundation</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Cancer Center - North Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Oakland-Broadway</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital - Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feather River Cancer Center</name>
      <address>
        <city>Paradise</city>
        <state>California</state>
        <zip>95969</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pomona Valley Hospital Medical Center</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Rancho Cordova Cancer Center</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rohnert Park Cancer Center</name>
      <address>
        <city>Rohnert Park</city>
        <state>California</state>
        <zip>94928</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Permanente Medical Group-Roseville Radiation Oncology</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at Davis Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Sacramento Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Cancer Treatment Center</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center - Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porter Adventist Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Littleton</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longmont United Hospital</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKee Medical Center</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health System-Christiana Hospital</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beebe Health Campus</name>
      <address>
        <city>Rehoboth Beach</city>
        <state>Delaware</state>
        <zip>19971</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital-Holtz Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Health System</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital-Forsyth</name>
      <address>
        <city>Cumming</city>
        <state>Georgia</state>
        <zip>30041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's-Candler Health System</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeward Radiation Oncology Center</name>
      <address>
        <city>'Ewa Beach</city>
        <state>Hawaii</state>
        <zip>96706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hawaii</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Liliha</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John H Stroger Jr Hospital of Cook County</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612-3785</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Illinois Masonic Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hospital</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Anderson Regional Hospital/Cancer Center</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Saint Margaret Health-Dyer Campus</name>
      <address>
        <city>Dyer</city>
        <state>Indiana</state>
        <zip>46311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Associates PC</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Saint Margaret Health-Hammond Campus</name>
      <address>
        <city>Hammond</city>
        <state>Indiana</state>
        <zip>46320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic PC-William R Bliss Cancer Center</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center-West Lakes</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Bird Perkins Cancer Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Regional Medical Center</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lowell General Hospital</name>
      <address>
        <city>Lowell</city>
        <state>Massachusetts</state>
        <zip>01854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber/Brigham and Women's Cancer Center at Milford Regional</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber/Brigham and Women's Cancer Center at South Shore</name>
      <address>
        <city>South Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>D'Amour Center for Cancer Care</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106-0995</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University/Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Hospital and Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Saint Mary's</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health at Butterworth Campus</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Macomb-Oakland Hospital</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Clinic North-Bemidgi</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridgeview Medical Center</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John's Mercy Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59107-7000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County</name>
      <address>
        <city>Mount Holly</city>
        <state>New Jersey</state>
        <zip>08060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Health Medical Center-Hopewell</name>
      <address>
        <city>Pennington</city>
        <state>New Jersey</state>
        <zip>08534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua West Jersey Hospital Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore-LIJ Health System/Center for Advanced Medicine</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Atlantic Radiation Oncology</name>
      <address>
        <city>Supply</city>
        <state>North Carolina</state>
        <zip>28462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Radiation Oncology</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hanover Regional Medical Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Bismarck Medical Center</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Akron City Hospital/Cooper Cancer Center</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Barberton Hospital</name>
      <address>
        <city>Barberton</city>
        <state>Ohio</state>
        <zip>44203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geaugra Hospital</name>
      <address>
        <city>Chardon</city>
        <state>Ohio</state>
        <zip>44024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mark H Zangmeister Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Health Center at Lake Medina</name>
      <address>
        <city>Medina</city>
        <state>Ohio</state>
        <zip>44256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake University Ireland Cancer Center</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest General Health Center Ireland Cancer Center</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHHS-Chagrin Highlands Medical Center</name>
      <address>
        <city>Orange Village</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Ohio Medical Center</name>
      <address>
        <city>Portsmouth</city>
        <state>Ohio</state>
        <zip>45662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHHS-Westlake Medical Center</name>
      <address>
        <city>Westlake</city>
        <state>Ohio</state>
        <zip>44145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paoli Memorial Hospital</name>
      <address>
        <city>Paoli</city>
        <state>Pennsylvania</state>
        <zip>19301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Therapy Oncology Group</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Nittany Medical Center</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reading Hospital</name>
      <address>
        <city>West Reading</city>
        <state>Pennsylvania</state>
        <zip>19611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Hospital</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Self Regional Healthcare</name>
      <address>
        <city>Greenwood</city>
        <state>South Carolina</state>
        <zip>29646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid City Regional Hospital</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Logan Regional Hospital</name>
      <address>
        <city>Logan</city>
        <state>Utah</state>
        <zip>84321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dixie Medical Center Regional Cancer Center</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LDS Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital</name>
      <address>
        <city>Federal Way</city>
        <state>Washington</state>
        <zip>98003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason CCOP</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edwards Comprehensive Cancer Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora BayCare Medical Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54311-6519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Saint Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora West Allis Medical Center</name>
      <address>
        <city>West Allis</city>
        <state>Wisconsin</state>
        <zip>53227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA-Cancer Centre for the Southern Interior</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA-Vancouver Island Cancer Centre</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 6V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Centre</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pamela Youde Nethersole Eastern Hospital</name>
      <address>
        <city>Chai Wan</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Hong Kong</country>
    <country>Singapore</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19.</citation>
    <PMID>32073955</PMID>
  </reference>
  <results_reference>
    <citation>Gil KM, Pugh SL, Klopp AH, Yeung AR, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Kachnic LA, Bruner DW. Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy. Gynecol Oncol. 2019 Jul;154(1):183-188. doi: 10.1016/j.ygyno.2019.04.682. Epub 2019 May 16.</citation>
    <PMID>31104905</PMID>
  </results_reference>
  <results_reference>
    <citation>Klopp AH, Yeung AR, Deshmukh S, Gil KM, Wenzel L, Westin SN, Gifford K, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Pugh SL, Kachnic LA, Bruner DW. Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203. J Clin Oncol. 2018 Aug 20;36(24):2538-2544. doi: 10.1200/JCO.2017.77.4273. Epub 2018 Jul 10. Erratum In: J Clin Oncol. 2019 Mar 20;37(9):761. J Clin Oncol. 2020 Apr 1;38(10):1118.</citation>
    <PMID>29989857</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>October 3, 2017</results_first_submitted>
  <results_first_submitted_qc>December 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 23, 2018</results_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastrointestinal complications</keyword>
  <keyword>perioperative/postoperative complications</keyword>
  <keyword>radiation toxicity</keyword>
  <keyword>urinary complications</keyword>
  <keyword>urinary tract toxicity</keyword>
  <keyword>endometrial clear cell carcinoma</keyword>
  <keyword>endometrial papillary serous carcinoma</keyword>
  <keyword>stage IA endometrial carcinoma</keyword>
  <keyword>stage IB endometrial carcinoma</keyword>
  <keyword>stage II endometrial carcinoma</keyword>
  <keyword>stage IIIA endometrial carcinoma</keyword>
  <keyword>stage IIIB endometrial carcinoma</keyword>
  <keyword>stage IIIC endometrial carcinoma</keyword>
  <keyword>endometrial adenocarcinoma</keyword>
  <keyword>cervical adenocarcinoma</keyword>
  <keyword>stage IB cervical cancer</keyword>
  <keyword>stage IIA cervical cancer</keyword>
  <keyword>stage IIB cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_id>NCT01672892-D1</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://nctn-data-archive.nci.nih.gov/</doc_url>
      <doc_comment>Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intensity-Modulated Radiation Therapy</title>
          <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
        <group group_id="P2">
          <title>Standard Radiation Therapy</title>
          <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Eligible Population</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Adverse Event Population</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Eligible patients</population>
      <group_list>
        <group group_id="B1">
          <title>Intensity-Modulated Radiation Therapy</title>
          <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
        <group group_id="B2">
          <title>Standard Radiation Therapy</title>
          <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="129"/>
            <count group_id="B2" value="149"/>
            <count group_id="B3" value="278"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" lower_limit="28" upper_limit="82"/>
                    <measurement group_id="B2" value="61" lower_limit="29" upper_limit="83"/>
                    <measurement group_id="B3" value="61" lower_limit="28" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="278"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation</title>
        <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
        <time_frame>Baseline and week 5 of RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, only 107/130 had data at both baseline and week 5 on the Intensity-Modulated Radiation Therapy arm, and only 126/149 had data at both baseline and week 5 on the Standard Radiation Therapy arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation</title>
          <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, only 107/130 had data at both baseline and week 5 on the Intensity-Modulated Radiation Therapy arm, and only 126/149 had data at both baseline and week 5 on the Standard Radiation Therapy arm.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="126"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.6" spread="18.7"/>
                    <measurement group_id="O2" value="-23.6" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0476</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment</title>
        <description>Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.</description>
        <time_frame>Baseline to Week 5 of RT</time_frame>
        <population>Adverse event data was not obtained from all eligible participants at 5 weeks from treatment start. Therefore, only 122/130 had data on the Intensity-Modulated Radiation Therapy arm, and only 136/149 had data at on the Standard Radiation Therapy arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment</title>
          <description>Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.</description>
          <population>Adverse event data was not obtained from all eligible participants at 5 weeks from treatment start. Therefore, only 122/130 had data on the Intensity-Modulated Radiation Therapy arm, and only 136/149 had data at on the Standard Radiation Therapy arm.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="136"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="18.4" upper_limit="34.4"/>
                    <measurement group_id="O2" value="22.1" lower_limit="15.1" upper_limit="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4338</p_value>
            <method>Binomial test of proportions</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Toxicity, as Measured by Change in EPIC Urinary Domain</title>
        <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
        <time_frame>Baseline, week 3 and 5 of RT, and 4-6 weeks after RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Arm A- 110/130 at baseline and week 3, 107/130 at baseline and week 5, 99/130 at baseline and 4-6 weeks; Arm B- 127/149 at baseline and week 3, 126/149 at baseline and week 5, 121/149 at baseline and 4-6 week.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy (A)</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy (B)</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Toxicity, as Measured by Change in EPIC Urinary Domain</title>
          <description>The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Arm A- 110/130 at baseline and week 3, 107/130 at baseline and week 5, 99/130 at baseline and 4-6 weeks; Arm B- 127/149 at baseline and week 3, 126/149 at baseline and week 5, 121/149 at baseline and 4-6 week.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 3 of RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="11.3"/>
                    <measurement group_id="O2" value="-6.0" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 of RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.6" spread="15.3"/>
                    <measurement group_id="O2" value="-10.4" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-6 Weeks Post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="13.0"/>
                    <measurement group_id="O2" value="-4.1" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 3 of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level of 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 5 of RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level of 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4-6 weeks post-RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.41</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level of 0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale</title>
        <description>The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires &gt;= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.</description>
        <time_frame>Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale</title>
          <description>The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires &gt;= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FACT-G total - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.4" spread="12.7"/>
                    <measurement group_id="O2" value="-7.6" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-G total 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="11.7"/>
                    <measurement group_id="O2" value="0.5" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-Cx subscale - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="6.1"/>
                    <measurement group_id="O2" value="-4.9" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-Cx subscale - 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="5.7"/>
                    <measurement group_id="O2" value="0.4" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical subscale - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="6.0"/>
                    <measurement group_id="O2" value="-6.1" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical - subscale - 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="4.9"/>
                    <measurement group_id="O2" value="-1.2" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional subscale - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="5.7"/>
                    <measurement group_id="O2" value="-1.6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional - subscale - 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="5.0"/>
                    <measurement group_id="O2" value="0.6" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional subscale - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="3.5"/>
                    <measurement group_id="O2" value="0.9" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional subscale - 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="3.1"/>
                    <measurement group_id="O2" value="1.9" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social subscale - 5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="5.4"/>
                    <measurement group_id="O2" value="-0.6" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social subscale - 4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="4.8"/>
                    <measurement group_id="O2" value="-0.8" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FACT-G total score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.54</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FACT-G total score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>FACT-G total score - 4-6 weeks post RT</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FACT-Cx subscale score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FACT-Cx subscale score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.45</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical subscale score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical subscale score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Functional subscale score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.55</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Functional subscale score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional subscale score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional subscale score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social subscale score - 5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.66</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social subscale score - 4-6 weeks post RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.0125</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Utilities, as Measured by Change From Baseline in EQ-5D</title>
        <description>The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.</description>
        <time_frame>Baseline, week 5 of RT, 4-6 weeks after RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Intensity-Modulated Radiation Therapy arm: 78/130 at baseline and week 5, 74/130 at baseline and 4-6 weeks post-RT; Standard Radiation Therapy arm: 91/149 at baseline and week 5, 89/149 at baseline and 4-6 weeks post-RT.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Health Utilities, as Measured by Change From Baseline in EQ-5D</title>
          <description>The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Intensity-Modulated Radiation Therapy arm: 78/130 at baseline and week 5, 74/130 at baseline and 4-6 weeks post-RT; Standard Radiation Therapy arm: 91/149 at baseline and week 5, 89/149 at baseline and 4-6 weeks post-RT.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.2"/>
                    <measurement group_id="O2" value="0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-6 weeks post-RT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.1"/>
                    <measurement group_id="O2" value="0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>5 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.61</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4-6 weeks post-RT</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.67</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>2-sided significance level = 0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local-regional Recurrence</title>
        <description>Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
        <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
        <population>Eligible participants [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Local-regional Recurrence</title>
          <description>Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
          <population>Eligible participants [later analysis]</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="1.1" upper_limit="8.1"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0.6" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.81</p_value>
            <method>Gray's test</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-free Survival</title>
        <description>Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
        <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
        <population>Eligible participants [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-free Survival</title>
          <description>Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
          <population>Eligible participants [later analysis]</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" lower_limit="79.2" upper_limit="91.9"/>
                    <measurement group_id="O2" value="80.8" lower_limit="74.2" upper_limit="87.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <method>Log Rank</method>
            <method_desc>Two-side significance level = 0.05</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
            <estimate_desc>Reference level = Intensity-Modulated Radiation Therapy</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
        <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.</time_frame>
        <population>Eligible participants [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.</description>
          <population>Eligible participants [later analysis]</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.4" lower_limit="87.7" upper_limit="97.2"/>
                    <measurement group_id="O2" value="97.0" lower_limit="94.1" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.53</p_value>
            <method>Log Rank</method>
            <method_desc>Two-sided significance level = 0.05</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
            <estimate_desc>Reference level = Intensity-Modulated Radiation Therapy</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers</title>
        <time_frame>Outcome measure will not be analyzed</time_frame>
        <population>The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Intensity-Modulated Radiation Therapy</title>
            <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
          <group group_id="O2">
            <title>Standard Radiation Therapy</title>
            <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
          </group>
        </group_list>
        <measure>
          <title>Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers</title>
          <population>The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)</title>
        <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.</description>
        <time_frame>Baseline and week 5 of RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants from both treatment arms combined.</description>
          </group>
        </group_list>
        <measure>
          <title>Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)</title>
          <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]</population>
          <units>standard deviation</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bowel Domain Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Domain Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Domain Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Domain Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)</title>
        <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.</description>
        <time_frame>Baseline and week 5 of RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants from both treatment arms combined.</description>
          </group>
        </group_list>
        <measure>
          <title>Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)</title>
          <description>The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>nonparametric one-sample t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Week 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>nonparametric one-sample t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)</title>
        <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.</description>
        <time_frame>Baseline and week 5 of RT</time_frame>
        <population>Participants with baseline EPIC and FACT-G scores [later analysis] Questionnaires were not completed by all eligible participants. Therefore, for both domains only 231/279 (arms combined) participants had both FACT-G and EPIC data at baseline, and 199/279 participants had both FACT-G and EPIC data at week 5. [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants from both treatment arms combined.</description>
          </group>
        </group_list>
        <measure>
          <title>Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)</title>
          <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.</description>
          <population>Participants with baseline EPIC and FACT-G scores [later analysis] Questionnaires were not completed by all eligible participants. Therefore, for both domains only 231/279 (arms combined) participants had both FACT-G and EPIC data at baseline, and 199/279 participants had both FACT-G and EPIC data at week 5. [later analysis]</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bowel Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Bowel domain at baseline</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>One-sample t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Bowel domain at week 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>One-sample t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Urinary domain at baseline</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>One-sample t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Urinary domain at week 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>One-sample t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)</title>
        <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.&#xD;
A positive change score represents a decline in function.</description>
        <time_frame>Baseline and week 5 of RT</time_frame>
        <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains only 234/279 (arms combined) participants had data at both baseline and week 5. [later analysis]</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants from both treatment arms combined.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)</title>
          <description>The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.&#xD;
A positive change score represents a decline in function.</description>
          <population>Questionnaires were not completed by all eligible participants. Therefore, for both domains only 234/279 (arms combined) participants had data at both baseline and week 5. [later analysis]</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bowel Domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.37" spread="19.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Domain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.11" spread="16.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Bowel domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Urinary domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. [Later analysis]</time_frame>
      <desc>Eligible participants with adverse event data. (With the longer follow-up, adverse event data was collected from more participants compared to outcome measure 2. )</desc>
      <group_list>
        <group group_id="E1">
          <title>Intensity-Modulated Radiation Therapy</title>
          <description>Intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
        <group group_id="E2">
          <title>Standard Radiation Therapy</title>
          <description>Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="122" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="136" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="113" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dermatitis radiation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Vaginal stricture</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="144"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="144"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Some outcome measures were analyzed at a later time (&quot;[later analysis]&quot;) and included a patient initially considered to be ineligible (protocol violation), but later deemed eligible, thus resulting in an additional participant for these results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Wendy Seiferheld, M.S.</name_or_title>
      <organization>NRG Oncology</organization>
      <email>seiferheldw@nrgoncology.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672892
org study id: RTOG-1203
secondary id: CDR0000738944
secondary id: NCI-2012-02001
nct id: NCT01672892
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
      tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to
      the tumor may kill more tumor cells and cause less damage to normal tissue.

      PURPOSE: This randomized phase III trial is studying two different methods of radiation and
      their side effects and comparing how well they work in treating endometrial and cervical
      cancer after surgery.
OBJECTIVES:

      Primary

        -  To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute
           gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as
           measured with the expanded prostate cancer index composite (EPIC) instrument.

      Secondary

        -  To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for
           Adverse Events version 4.0 [CTCAE v. 4.0]) is reduced with IMRT compared to conventional
           whole-pelvis radiation therapy (WPRT).

        -  To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT
           compared to conventional WPRT.

        -  To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain.

        -  To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic
           radiation treatment or four-field pelvic radiation treatment for endometrial or cervical
           cancer.

        -  To assess the impact of pelvic IMRT on quality of life using the Functional Assessment
           of Cancer Therapy-General (FACT-G) with cervix subscale.

        -  To determine if there is any difference in local-regional control, disease-free
           survival, and overall survival between patients treated with IMRT as compared to
           conventional WPRT.

        -  To perform a health-utilities analysis to measure the financial impact of pelvic IMRT
           via the EQ-5D instrument.

        -  To identify molecular predictors of radiation toxicity and novel circulating cancer
           biomarkers.

      OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer
      (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²),
      and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up
           to 5-6 weeks.

        -  Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for
           up to 5-6 weeks.

      Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5
      weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or
      disease progression.

      Tissue and blood samples may be collected for biomarker and correlative analysis.

      Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer
      Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version
      4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome
      [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.

      After completion of study therapy, patients are followed every 6 months for the first 2 years
      and then annually for 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation
time frame: Baseline and week 5 of RT
description: The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
measure: Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment
time frame: Baseline to Week 5 of RT
description: Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
measure: Urinary Toxicity, as Measured by Change in EPIC Urinary Domain
time frame: Baseline, week 3 and 5 of RT, and 4-6 weeks after RT
description: The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
measure: Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale
time frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT
description: The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.
measure: Health Utilities, as Measured by Change From Baseline in EQ-5D
time frame: Baseline, week 5 of RT, 4-6 weeks after RT
description: The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.
measure: Local-regional Recurrence
time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
description: Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
measure: Disease-free Survival
time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
description: Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
measure: Overall Survival
time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.
description: Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
measure: Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers
time frame: Outcome measure will not be analyzed
measure: Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)
time frame: Baseline and week 5 of RT
description: The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.
measure: Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)
time frame: Baseline and week 5 of RT
description: The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.
measure: Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)
time frame: Baseline and week 5 of RT
description: The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
measure: Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)
time frame: Baseline and week 5 of RT
description: The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.
A positive change score represents a decline in function.
arm group label: Intensity-Modulated Radiation Therapy
arm group type: Experimental
description: intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
arm group label: Standard Radiation Therapy
arm group type: Active Comparator
description: Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy
intervention type: Radiation
intervention name: Standard radiation therapy
description: Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
arm group label: Intensity-Modulated Radiation Therapy
other name: RT
intervention type: Radiation
intervention name: intensity-modulated radiation therapy
description: Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
arm group label: Standard Radiation Therapy
other name: IMRT
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann Klopp, MD, PhD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
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country: Canada
country: Hong Kong
country: Singapore
country: United States
citation: Yeung AR, Pugh SL, Klopp AH, Gil KM, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Bruner DW, Kachnic LA. Improvement in Patient-Reported Outcomes With Intensity-Modulated Radiotherapy (RT) Compared With Standard RT: A Report From the NRG Oncology RTOG 1203 Study. J Clin Oncol. 2020 May 20;38(15):1685-1692. doi: 10.1200/JCO.19.02381. Epub 2020 Feb 19.
PMID: 32073955
citation: Gil KM, Pugh SL, Klopp AH, Yeung AR, Wenzel L, Westin SN, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Deshmukh S, Kachnic LA, Bruner DW. Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy. Gynecol Oncol. 2019 Jul;154(1):183-188. doi: 10.1016/j.ygyno.2019.04.682. Epub 2019 May 16.
PMID: 31104905
citation: Klopp AH, Yeung AR, Deshmukh S, Gil KM, Wenzel L, Westin SN, Gifford K, Gaffney DK, Small W Jr, Thompson S, Doncals DE, Cantuaria GHC, Yaremko BP, Chang A, Kundapur V, Mohan DS, Haas ML, Kim YB, Ferguson CL, Pugh SL, Kachnic LA, Bruner DW. Patient-Reported Toxicity During Pelvic Intensity-Modulated Radiation Therapy: NRG Oncology-RTOG 1203. J Clin Oncol. 2018 Aug 20;36(24):2538-2544. doi: 10.1200/JCO.2017.77.4273. Epub 2018 Jul 10. Erratum In: J Clin Oncol. 2019 Mar 20;37(9):761. J Clin Oncol. 2020 Apr 1;38(10):1118.
PMID: 29989857
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Postoperative Complications
study doc: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Some outcome measures were analyzed at a later time ("[later analysis]") and included a patient initially considered to be ineligible (protocol violation), but later deemed eligible, thus resulting in an additional participant for these results.
point of contact: 