<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/NCT03786354</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-18201</org_study_id>
    <secondary_id>NCI-2018-02307</secondary_id>
    <nct_id>NCT03786354</nct_id>
  </id_info>
  <brief_title>Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer</brief_title>
  <official_title>Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies the shoulder morbidity in patients with lymph-node positive&#xD;
      breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal&#xD;
      radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm&#xD;
      morbidity in patients with lymph-node positive breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year&#xD;
      patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI)&#xD;
      for lymph-node positive breast cancer as compared to historical data.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To measure patient-reported shoulder/arm morbidity in women receiving RNI with&#xD;
      3-dimensional conformal radiation therapy (3DCRT) for lymph-node positive breast cancer.&#xD;
&#xD;
      II. To measure change in shoulder range of motion in women receiving RNI. III. To measures&#xD;
      rates of ipsilateral upper extremity lymphedema in women receiving RNI.&#xD;
&#xD;
      IV. To explore the dose volume parameters to the shoulder/neck/trunk musculature associated&#xD;
      with worsening patient-reported shoulder/arm morbidity.&#xD;
&#xD;
      V. To assess disease outcomes in patients treated with IMRT. VI. To measure long-term&#xD;
      patient-reported shoulder/arm morbidity in women receiving RNI with IMRT or 3DCRT.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients undergo IMRT over 5 weeks.&#xD;
&#xD;
      ARM B: Patients undergo 3DCRT over 5 weeks.&#xD;
&#xD;
      After completion study treatment, patients are followed up at 1, 6, and 12 months, and then&#xD;
      annually for up to 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)</measure>
    <time_frame>At 1 year</time_frame>
    <description>DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. The full scale range is 0-100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)</measure>
    <time_frame>At 1 year</time_frame>
    <description>DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in shoulder range of motion for flexion, abduction, internal and external rotation using a goniometer as defined by the American Academy of Orthopedic Surgeons</measure>
    <time_frame>At baseline, 1 month, 6 months and 12 months post-radiation</time_frame>
    <description>Using a goniometer as defined by the American Academy of Orthopedic Surgeons to measure changes in shoulder range of motion for flexion, abduction, internal and external rotation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure rates of upper extremity lymphedema using arm circumference with a tape measure</measure>
    <time_frame>At baseline, 1 month, 6 months and 12 months post-radiation</time_frame>
    <description>Measure rates of upper extremity lymphedema using arm circumference using a tape measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure rates of upper extremity lymphedema using a perometer</measure>
    <time_frame>At baseline, 1 month, 6 months and 12 months post-radiation</time_frame>
    <description>Measure rates of upper extremity lymphedema using arm circumference using a perometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of loco-regional control in patients treated with IMRT</measure>
    <time_frame>At 5 years</time_frame>
    <description>Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases in patients treated with IMRT</measure>
    <time_frame>At 5 years</time_frame>
    <description>The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival in patients treated with IMRT</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Anatomic Stage II Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIA Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIB Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage III Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIA Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIB Breast Cancer AJCC v8</condition>
  <condition>Anatomic Stage IIIC Breast Cancer AJCC v8</condition>
  <condition>Lymph Node Involvement</condition>
  <condition>Prognostic Stage II Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIA Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIB Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage III Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIA Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIB Breast Cancer AJCC v8</condition>
  <condition>Prognostic Stage IIIC Breast Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm A (IMRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (3DCRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>3-Dimensional Conformal Radiation Therapy</intervention_name>
    <description>Undergo 3DCRT</description>
    <arm_group_label>Arm B (3DCRT)</arm_group_label>
    <other_name>3-dimensional radiation therapy</other_name>
    <other_name>3D CONFORMAL RADIATION THERAPY</other_name>
    <other_name>3D CRT</other_name>
    <other_name>3D-CRT</other_name>
    <other_name>Conformal Therapy</other_name>
    <other_name>Radiation Conformal Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy</intervention_name>
    <description>Undergo IMRT</description>
    <arm_group_label>Arm A (IMRT)</arm_group_label>
    <other_name>IMRT</other_name>
    <other_name>Intensity Modulated RT</other_name>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically proven diagnosis of breast cancer&#xD;
&#xD;
          -  Patients that receive neoadjuvant systemic therapy (chemotherapy, anti-HER2 therapy,&#xD;
             or endocrine therapy) are eligible&#xD;
&#xD;
          -  History/physical examination within 60 days prior to study entry&#xD;
&#xD;
          -  Patients who have undergone either a lumpectomy or mastectomy are eligible&#xD;
&#xD;
          -  Patients that have undergone any type of breast reconstruction are eligible&#xD;
&#xD;
          -  The interval between the date of last surgery or chemotherapy and registration must be&#xD;
             =&lt; 84 days&#xD;
&#xD;
          -  Women of childbearing potential must have a negative urine or serum pregnancy test&#xD;
             within 14 days of start of radiation therapy&#xD;
&#xD;
          -  Women of childbearing potential must be non-pregnant and non-lactating and willing to&#xD;
             use medically acceptable form of contraception during radiation therapy&#xD;
&#xD;
          -  Patients must provide study specific informed consent prior to study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or radiologic evidence of distant metastases&#xD;
&#xD;
          -  Patients with known unresected disease in the axillary apex or supraclavicular fossa&#xD;
&#xD;
          -  Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in&#xD;
             situ [LCIS] is eligible)&#xD;
&#xD;
          -  Prior surgery to the ipsilateral shoulder for any condition&#xD;
&#xD;
          -  Baseline impaired mobility of the ipsilateral shoulder from a condition not related to&#xD;
             the breast cancer surgery as determined by the treating physician&#xD;
&#xD;
          -  Non-epithelial breast malignancies such as sarcoma/lymphoma&#xD;
&#xD;
          -  Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral&#xD;
             breast that would result in overlap of radiation fields&#xD;
&#xD;
          -  Medical, psychiatric, or other conditions that would prevent the patient from&#xD;
             receiving the protocol therapy or providing informed consent&#xD;
&#xD;
          -  Pregnancy or women of childbearing potential who are sexually active and not&#xD;
             willing/able to use medically acceptable forms of contraception&#xD;
&#xD;
          -  Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis&#xD;
             with active rash&#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>Sasha Beyer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Sasha Beyer</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03786354
org study id: OSU-18201
secondary id: NCI-2018-02307
nct id: NCT03786354
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This phase II trial studies the shoulder morbidity in patients with lymph-node positive
      breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal
      radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm
      morbidity in patients with lymph-node positive breast cancer.
PRIMARY OBJECTIVES:

      I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year
      patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI)
      for lymph-node positive breast cancer as compared to historical data.

      SECONDARY OBJECTIVES:

      I. To measure patient-reported shoulder/arm morbidity in women receiving RNI with
      3-dimensional conformal radiation therapy (3DCRT) for lymph-node positive breast cancer.

      II. To measure change in shoulder range of motion in women receiving RNI. III. To measures
      rates of ipsilateral upper extremity lymphedema in women receiving RNI.

      IV. To explore the dose volume parameters to the shoulder/neck/trunk musculature associated
      with worsening patient-reported shoulder/arm morbidity.

      V. To assess disease outcomes in patients treated with IMRT. VI. To measure long-term
      patient-reported shoulder/arm morbidity in women receiving RNI with IMRT or 3DCRT.

      OUTLINE: Patients are assigned to 1 of 2 arms.

      ARM A: Patients undergo IMRT over 5 weeks.

      ARM B: Patients undergo 3DCRT over 5 weeks.

      After completion study treatment, patients are followed up at 1, 6, and 12 months, and then
      annually for up to 5 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
time frame: At 1 year
description: DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. The full scale range is 0-100.
measure: Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)
time frame: At 1 year
description: DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity.
measure: Changes in shoulder range of motion for flexion, abduction, internal and external rotation using a goniometer as defined by the American Academy of Orthopedic Surgeons
time frame: At baseline, 1 month, 6 months and 12 months post-radiation
description: Using a goniometer as defined by the American Academy of Orthopedic Surgeons to measure changes in shoulder range of motion for flexion, abduction, internal and external rotation
measure: Measure rates of upper extremity lymphedema using arm circumference with a tape measure
time frame: At baseline, 1 month, 6 months and 12 months post-radiation
description: Measure rates of upper extremity lymphedema using arm circumference using a tape measure
measure: Measure rates of upper extremity lymphedema using a perometer
time frame: At baseline, 1 month, 6 months and 12 months post-radiation
description: Measure rates of upper extremity lymphedema using arm circumference using a perometer
measure: Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH
time frame: Up to 5 years
description: Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH
measure: Rates of loco-regional control in patients treated with IMRT
time frame: At 5 years
description: Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT
measure: Distant metastases in patients treated with IMRT
time frame: At 5 years
description: The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases
measure: Overall survival in patients treated with IMRT
time frame: Up to 5 years
description: Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT
measure: Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT
time frame: Up to 5 years
description: DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100
measure: Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT
time frame: Up to 5 years
description: DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity
arm group label: Arm A (IMRT)
arm group type: Experimental
description: Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
arm group label: Arm B (3DCRT)
arm group type: Experimental
description: Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
intervention type: Radiation
intervention name: 3-Dimensional Conformal Radiation Therapy
description: Undergo 3DCRT
arm group label: Arm B (3DCRT)
other name: 3-dimensional radiation therapy
other name: 3D CONFORMAL RADIATION THERAPY
other name: 3D CRT
other name: 3D-CRT
other name: Conformal Therapy
other name: Radiation Conformal Therapy
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy
description: Undergo IMRT
arm group label: Arm A (IMRT)
other name: IMRT
other name: Intensity Modulated RT
other name: Intensity-Modulated Radiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sasha Beyer, MD, PhD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Sasha Beyer
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No