<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/NCT02979691</url>
  </required_header>
  <id_info>
    <org_study_id>3JECROG P-01</org_study_id>
    <nct_id>NCT02979691</nct_id>
  </id_info>
  <brief_title>Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01</brief_title>
  <official_title>A Phase II/III Study Comparing Simultaneous Integrated Boost (SIB) Intensity Modulated Radiation Therapy (IMRT) With S1 Based SIB-IMRT Followed by Adjuvant Chemotherapy With S1 in Elderly Patients With Esophageal or Esophagogastric Cancer (3JECROG-P01)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anyang Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tengzhou Central People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Inner Mongolia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Cancer Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Ratiotherapy alone is the current standard treatment for elderly esophageal or&#xD;
      esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly&#xD;
      patients. This study aimed to assess the efficiency and safety of simultaneous integrated&#xD;
      boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by&#xD;
      adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric&#xD;
      cancer patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</primary_completion_date>
  <phase>Phase 2/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>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comprehensive geriatric assessment</measure>
    <time_frame>Baseline</time_frame>
    <description>A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation in which multiple problems of older persons are described.It consists several questionnaires used to assess an older individual's functional status,comorbid medical condition,cognition, psychologic state, social support, and nutritional status,etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate of dysphagia</measure>
    <time_frame>Change from baseline to 1 month after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of locoregional control and failure site within or outside radiation field</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiotherapy toxicities</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemoradiotherapy toxicities</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>CT/MRI Texture Features in evaluating the tumor response and prognosis</measure>
    <time_frame>Change from baseline to 1 month after treatment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical target contouring guided by MRI or CT simulation</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Esophagus Cancer</condition>
  <condition>Esophagogastric Junction Cancer</condition>
  <condition>Radiotherapy; Complications</condition>
  <condition>Chemoradiation</condition>
  <arm_group>
    <arm_group_label>SIB-IMRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S1 based SIB-IMRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SIB-IMRT</intervention_name>
    <arm_group_label>S1 based SIB-IMRT</arm_group_label>
    <arm_group_label>SIB-IMRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S-1</intervention_name>
    <arm_group_label>S1 based SIB-IMRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥70 years&#xD;
&#xD;
          -  Esophageal or Esophagogastric cancer&#xD;
&#xD;
          -  Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as&#xD;
             IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes&#xD;
             metastasis)&#xD;
&#xD;
          -  Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3&#xD;
&#xD;
          -  No distant metastasis other than supraclavicular lymph nodes&#xD;
&#xD;
          -  No prior history of thoracic radiation&#xD;
&#xD;
          -  Patients must have normal organ and marrow function as defined below: Leukocytes:&#xD;
             greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3&#xD;
             .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal&#xD;
             institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit;&#xD;
             Creatinine within normal upper limits&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other cancer history except cervical carcinoma in situ and non-malignant&#xD;
             melanoma skin cancer&#xD;
&#xD;
          -  With any distant metastasis out of regional lymphatic drainage or in&#xD;
             liver,lung,bone,CNS,etc&#xD;
&#xD;
          -  History of allergic reactions attributed to similar chemical or biologic complex to&#xD;
             S-1&#xD;
&#xD;
          -  With esophageal fistula, perforation, cachexia prior to treatment&#xD;
&#xD;
          -  Uncontrolled illness including, but not limited to, active infection, symptomatic&#xD;
             heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness&#xD;
&#xD;
          -  History of myocardial infarction within the past 6 months or history of ventricular&#xD;
             arrhythmia&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zefen Xiao</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal 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/NCT02979691
org study id: 3JECROG P-01
nct id: NCT02979691
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Ratiotherapy alone is the current standard treatment for elderly esophageal or
      esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly
      patients. This study aimed to assess the efficiency and safety of simultaneous integrated
      boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by
      adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric
      cancer patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 1 year
measure: Comprehensive geriatric assessment
time frame: Baseline
description: A comprehensive geriatric assessment (CGA) is a multidisciplinary evaluation in which multiple problems of older persons are described.It consists several questionnaires used to assess an older individual's functional status,comorbid medical condition,cognition, psychologic state, social support, and nutritional status,etc.
measure: Remission rate of dysphagia
time frame: Change from baseline to 1 month after treatment
measure: Progression free survival
time frame: 1 year
measure: Time of locoregional control and failure site within or outside radiation field
time frame: 1 year
measure: Radiotherapy toxicities
time frame: 2 months
measure: Chemoradiotherapy toxicities
time frame: 2 months
measure: Analysis of relationship between dosimetric parameters of radiation technique and acute or late side effects
time frame: 6 months
measure: CT/MRI Texture Features in evaluating the tumor response and prognosis
time frame: Change from baseline to 1 month after treatment
measure: Clinical target contouring guided by MRI or CT simulation
time frame: Baseline
arm group label: SIB-IMRT
arm group type: Active Comparator
description: SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).
arm group label: S1 based SIB-IMRT
arm group type: Experimental
description: S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.
intervention type: Radiation
intervention name: SIB-IMRT
arm group label: S1 based SIB-IMRT
arm group label: SIB-IMRT
intervention type: Drug
intervention name: S-1
arm group label: S1 based SIB-IMRT
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Zefen Xiao
investigator title: Dr.
mesh term: Esophageal Neoplasms