<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/NCT04453904</url>
  </required_header>
  <id_info>
    <org_study_id>2020PHB013-01</org_study_id>
    <nct_id>NCT04453904</nct_id>
  </id_info>
  <brief_title>Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer</brief_title>
  <official_title>A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometrial cancer is the most common gynecological malignancy affecting women's health.&#xD;
      About 15% of the patients will have local late disease (stage III) with high risk of&#xD;
      recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy&#xD;
      is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still&#xD;
      uncertain. The retrospective data of our center showed that the sequential radiochemotherapy&#xD;
      of &quot;chemotherapy-radiotherapy-chemotherapy&quot; in the &quot;sanwich&quot; mode could improve the survival&#xD;
      outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized&#xD;
      controlled study to compare the &quot;sanwich&quot; mode of radiochemotherapy and the &quot;concurrent&#xD;
      chemoradiotherapy followed by chemotherapy&quot; mode will be carried out to determine the better&#xD;
      modality of radiochemotherapy in stage III endometrial adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Anticipated">April 2027</completion_date>
  <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
  <phase>N/A</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>Progress-free survival</measure>
    <time_frame>From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months</time_frame>
    <description>To determine if treatment with radiochemotherapy in &quot;sanwich&quot; mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From the date of randomization until the date of death from any cause, assessed up to 60 months</time_frame>
    <description>To determine if treatment with radiochemotherapy in &quot;sanwich&quot; mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of death (i.e., increases survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effect</measure>
    <time_frame>through study completion,an average of 1 year</time_frame>
    <description>To compare the modalities with respect to acute and late adverse effects of therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient-reported Quality of Life</measure>
    <time_frame>3 months after treatment and 1 year after treatment</time_frame>
    <description>To determine the impact on patient-reported Quality of Life (using the questionnaire of combining the items from FACT-G, FACT/GOG-NTX-4 subscale (4 items) and items C3 and C5 from the FACT-C)during and following treatment for up to 1 year with the two treatment regimens.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">654</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>sequential radiochemotherapy in a &quot;sanwich&quot; mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two courses of TC regimen chemotherapy (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) will be given first, followed by external pelvic radiation (± vaginal brachytherapy), and then four courses of the same regime consolidation chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>concurrent chemoradiotherapy followed by chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>External pelvic radiation (± vaginal brachytherapy) will be given after operation. On the first day and the 29th day of radiotherapy, concurrent intravenous cisplatin (50mg/m2) will be given. After the concurrent radiochemotherapy, four courses of TC regimen (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) chemotherapy will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sequential radiochemotherapy in a &quot;sanwich&quot; mode</intervention_name>
    <description>Patients will randomized into two different modalities of radiochemotherapy.</description>
    <arm_group_label>concurrent chemoradiotherapy followed by chemotherapy</arm_group_label>
    <arm_group_label>sequential radiochemotherapy in a &quot;sanwich&quot; mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients of primary treatment&#xD;
&#xD;
          2. All patients must have undertaken comprehensive staging operation（Surgery must have&#xD;
             included a hysterectomy and bilateral salpingooophorectomy and surgical staging).&#xD;
&#xD;
          3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.&#xD;
&#xD;
          4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009&#xD;
             staging criteria.&#xD;
&#xD;
          5. Entry into the study is limited to no more than 8 weeks from the date of surgery.&#xD;
&#xD;
          6. Patients with adequate organ function, reflected by the following parameters:&#xD;
&#xD;
               1. WBC ≥ Normal value of the institution;&#xD;
&#xD;
               2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;&#xD;
&#xD;
               3. Platelet count ≥ 100,000/mcl;&#xD;
&#xD;
               4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;&#xD;
&#xD;
               5. Bilirubin ≤ 1.5 X ULN;&#xD;
&#xD;
               6. Creatinine ≤ institutional ULN.&#xD;
&#xD;
          7. Patients with a Karnofsky score≥60.&#xD;
&#xD;
          8. The patients should voluntarily join the study, sign an approved informed consent with&#xD;
             good compliance and cooperation with the follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or&#xD;
             endocrine therapy).&#xD;
&#xD;
          2. Patients with residual tumor after surgery.&#xD;
&#xD;
          3. Patients with other invasive malignancies.&#xD;
&#xD;
          4. Patients with contraindications of radiotherapy and chemotherapy (with a history of&#xD;
             myocardial infarction within 3 month, unstable angina pectoris or history of&#xD;
             uncontrolled arrhythmia s from the date of registration) and who cannot receive&#xD;
             postoperative adjuvant radiotherapy and chemotherapy.&#xD;
&#xD;
          5. Patients with an estimated survival of less than 6 months.&#xD;
&#xD;
          6. Those who are unable or unwilling to comply with the research requirements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Guo Zhang, Ph.D</last_name>
    <phone>+861088324381</phone>
    <email>zhangguo-2005@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jianliu Wang</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianliu Wang, Doctor</last_name>
      <email>wangjianliu@pkuph.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>radiochemotherapy</keyword>
  <keyword>sanwich mode</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04453904
org study id: 2020PHB013-01
nct id: NCT04453904
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Endometrial cancer is the most common gynecological malignancy affecting women's health.
      About 15% of the patients will have local late disease (stage III) with high risk of
      recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy
      is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still
      uncertain. The retrospective data of our center showed that the sequential radiochemotherapy
      of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival
      outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized
      controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent
      chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better
      modality of radiochemotherapy in stage III endometrial adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progress-free survival
time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months
description: To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.
measure: Overall survival
time frame: From the date of randomization until the date of death from any cause, assessed up to 60 months
description: To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of death (i.e., increases survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.
measure: adverse effect
time frame: through study completion,an average of 1 year
description: To compare the modalities with respect to acute and late adverse effects of therapy.
measure: patient-reported Quality of Life
time frame: 3 months after treatment and 1 year after treatment
description: To determine the impact on patient-reported Quality of Life (using the questionnaire of combining the items from FACT-G, FACT/GOG-NTX-4 subscale (4 items) and items C3 and C5 from the FACT-C)during and following treatment for up to 1 year with the two treatment regimens.
arm group label: sequential radiochemotherapy in a "sanwich" mode
arm group type: Experimental
description: Two courses of TC regimen chemotherapy (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) will be given first, followed by external pelvic radiation (± vaginal brachytherapy), and then four courses of the same regime consolidation chemotherapy.
arm group label: concurrent chemoradiotherapy followed by chemotherapy
arm group type: Active Comparator
description: External pelvic radiation (± vaginal brachytherapy) will be given after operation. On the first day and the 29th day of radiotherapy, concurrent intravenous cisplatin (50mg/m2) will be given. After the concurrent radiochemotherapy, four courses of TC regimen (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) chemotherapy will be given.
intervention type: Other
intervention name: sequential radiochemotherapy in a "sanwich" mode
description: Patients will randomized into two different modalities of radiochemotherapy.
arm group label: concurrent chemoradiotherapy followed by chemotherapy
arm group label: sequential radiochemotherapy in a "sanwich" mode
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Guo Zhang, Ph.D
phone: +861088324381
email: zhangguo-2005@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Endometrial Neoplasms