<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/NCT03817268</url>
  </required_header>
  <id_info>
    <org_study_id>CAPOGA-01</org_study_id>
    <nct_id>NCT03817268</nct_id>
  </id_info>
  <brief_title>Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection</brief_title>
  <acronym>CAPOGA</acronym>
  <official_title>Capecitabine or Observation for Patients With pT1N+M0 or pT2-3N0M0 Gastric Adenocarcinoma Undergoing R0 Resection (CAPOGA): A Large Multicenter Phase III Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Anhui Medical University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early&#xD;
      (stage T1) GC, it has been found by analyzing surgical specimens that ~5% of cancers have&#xD;
      lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable&#xD;
      probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN),&#xD;
      the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology&#xD;
      (ESMO) guidelines recommend adjuvant therapy for most patients with resected &gt;T1N0 GCs, the&#xD;
      recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or&#xD;
      T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this&#xD;
      patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a&#xD;
      definitive recommendation on this issue. Through careful literature search, there is not yet&#xD;
      randomized report on whether postsurgical chemotherapy benefits survival for patients with&#xD;
      resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil&#xD;
      plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent&#xD;
      and less severe adverse effects. This large multicenter phase III randomized controlled trial&#xD;
      is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui&#xD;
      Medical University, and carried out in multiple Chinese centers, aiming to compare the safety&#xD;
      and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for&#xD;
      patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 16, 2026</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free/Relapse-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>The time interval from randomization to death from any cause or end of follow-up whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30</measure>
    <time_frame>5 years</time_frame>
    <description>Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">768</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Capecitabine monotherapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine monotherapy</intervention_name>
    <description>Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.</description>
    <arm_group_label>Capecitabine monotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Microscopically-confirmed gastric adenocarcinoma (cardia cancer/adenocarcinoma of the&#xD;
             esophagogastric junction);&#xD;
&#xD;
          -  Cancer stage pT1N+M0 or pT2-3N0M0;&#xD;
&#xD;
          -  Radical R0 resection;&#xD;
&#xD;
          -  Retrieved lymph node number ≥15;&#xD;
&#xD;
          -  Without hepatic, peritoneal, or other distant metastasis;&#xD;
&#xD;
          -  Aged 18-70 years;&#xD;
&#xD;
          -  No other cancer-directed therapy except primary cancer resection;&#xD;
&#xD;
          -  Good tissue and organ function: white blood cell count ≥4000/mm3; neutrophil count&#xD;
             ≥1500/mm3; platelet count ≥100000/mm3; total bilirubin ≤25.7 μmol/L or within 1.5&#xD;
             times the upper threshold; aspartate transaminase (AST) and alanine transaminase (ALT)&#xD;
             within 2.5 times the upper threshold; creatinine within 1.25 times the upper&#xD;
             threshold; creatinine clearance rate &gt;60 mL/min;&#xD;
&#xD;
          -  No serious cardiovascular or cerebrovascular disease;&#xD;
&#xD;
          -  No concomitant or previous malignancies;&#xD;
&#xD;
          -  Enrolled within 6 weeks after resection;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) score ≤2;&#xD;
&#xD;
          -  Clavien-Dindo morbidity score 0-2;&#xD;
&#xD;
          -  Patient informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The need to take phenytoin or coumarin anti-coagulates;&#xD;
&#xD;
          -  Allergic to capecitabine or fluorouracil;&#xD;
&#xD;
          -  Known DPD activity deficiency (DPYD gene mutation);&#xD;
&#xD;
          -  Pregnant or breeding women;&#xD;
&#xD;
          -  All others contradictory to the items listed in the Inclusion Criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A-Man Xu, MD</last_name>
      <phone>+49-13705695470</phone>
      <email>amanxu@163.com</email>
    </contact>
    <contact_backup>
      <email>amanxu@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 17, 2020</last_update_submitted>
  <last_update_submitted_qc>April 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Anhui Medical University</investigator_affiliation>
    <investigator_full_name>A-Man Xu</investigator_full_name>
    <investigator_title>Professor, Chief Surgeon, Department Head</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03817268
org study id: CAPOGA-01
nct id: NCT03817268
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Gastric cancer (GC) is one of the most common and lethal malignancies in Asia. For early
      (stage T1) GC, it has been found by analyzing surgical specimens that ~5% of cancers have
      lymph node metastasis. For patients with stage T2-3N0M0 GCs, there is a considerable
      probability of micro-metastasis. While the US National Comprehensive Cancer Network (NCCN),
      the Japanese Gastric Cancer Association (JGCA), and the European Society for Medical Oncology
      (ESMO) guidelines recommend adjuvant therapy for most patients with resected >T1N0 GCs, the
      recommendations vary regarding postsurgical treatment for patients with stage T1N+M0 or
      T2-3N0M0 disease. The JGCA guidelines do not recommend postsurgical chemotherapy for this
      patient population, while the ESMO support the adjuvant treatment. The NCCN has not offered a
      definitive recommendation on this issue. Through careful literature search, there is not yet
      randomized report on whether postsurgical chemotherapy benefits survival for patients with
      resected T1N+M0 or T2-3N0M0 GC. The first-line chemotherapy regimen for GC is fluorouracil
      plus platinum. Among fluorouracil, platinum is especially favored due to its less frequent
      and less severe adverse effects. This large multicenter phase III randomized controlled trial
      is led by Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui
      Medical University, and carried out in multiple Chinese centers, aiming to compare the safety
      and efficacy of capecitabine monotherapy versus no therapy in the adjuvant setting for
      patients with stage T1N+M0 or T2-3N0M0 GC undergoing R0 Resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Disease-free/Relapse-free survival
time frame: 5 years
description: The time interval from randomization to local recurrence/distant metastasis, death, or end of follow-up whichever occurs first.
measure: Overall survival
time frame: 5 years
description: The time interval from randomization to death from any cause or end of follow-up whichever occurs first.
measure: Incidence of Treatment-Emergent Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
time frame: 2 years
description: Incidence of Treatment-Emergent/Drug-Associated Adverse Events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events
measure: Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30
time frame: 5 years
description: Health-related quality of life as assessed by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30. Except for the last 2 questions, for the first 28 questions higher values represent a worse outcome.
arm group label: Capecitabine monotherapy group
arm group type: Experimental
arm group label: Control group
arm group type: No Intervention
intervention type: Drug
intervention name: Capecitabine monotherapy
description: Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.
arm group label: Capecitabine monotherapy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Anhui Medical University
investigator full name: A-Man Xu
investigator title: Professor, Chief Surgeon, Department Head
mesh term: Adenocarcinoma
mesh term: Capecitabine
sharing ipd: Undecided