<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/NCT01665274</url>
  </required_header>
  <id_info>
    <org_study_id>GCPCT1205/repeat</org_study_id>
    <nct_id>NCT01665274</nct_id>
  </id_info>
  <brief_title>Efficiency of XELOX Neoadjuvant Chemotherapy in Gastric Cancer</brief_title>
  <acronym>repeat</acronym>
  <official_title>A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative&#xD;
      chemotherapy is superior or not to operation directly for locally advanced gastric cancer in&#xD;
      terms of 3 year disease-free survival (DFS) rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients of gastric cancer have been divided into two parts in random.The test group&#xD;
      receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the&#xD;
      same program after operation. The two groups have the same staging and eligibility&#xD;
      criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate&#xD;
      maybe the last evaluation standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    we are working on a larger similar multicenter cinical trials as a participant.so in order to&#xD;
    avoid conflicts of interest, we have to suspended this project.&#xD;
  </why_stopped>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">September 2022</completion_date>
  <primary_completion_date type="Actual">August 2020</primary_completion_date>
  <phase>Phase 2</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>3-year DFS</measure>
    <time_frame>3 years after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>From date of randomization until the end of the study, assessed up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate</measure>
    <time_frame>evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>after the pathological examination of resected speciments ie within 1 month after the operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>XELOX adjuvant group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>D2 resection&#xD;
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XELOX neoadjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.&#xD;
D2 resection&#xD;
After operation:&#xD;
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine 1,000 mg/m² twice daily, d1-14, q3w</description>
    <arm_group_label>XELOX adjuvant group</arm_group_label>
    <arm_group_label>XELOX neoadjuvant</arm_group_label>
    <other_name>xeloda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Oxaliplatin IV infusion, 130mg/m² d1, q3w</description>
    <arm_group_label>XELOX adjuvant group</arm_group_label>
    <arm_group_label>XELOX neoadjuvant</arm_group_label>
    <other_name>eloxatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>D2 resection</intervention_name>
    <description>D2 resection</description>
    <arm_group_label>XELOX adjuvant group</arm_group_label>
    <arm_group_label>XELOX neoadjuvant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Karnofsky performance status of ≥60 %.&#xD;
&#xD;
          -  Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically,&#xD;
             stage cT2-4N+M0, and cT4N0M0.&#xD;
&#xD;
          -  Patients had to have adequate renal function (serum creatinine ≤1 times the upper&#xD;
             limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN,&#xD;
             aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5&#xD;
             times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil&#xD;
             count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including&#xD;
             presence of tumor cells in the ascites).&#xD;
&#xD;
          -  Sexually active males and females (of childbearing potential) unwilling to practice&#xD;
             contraception during the study.&#xD;
&#xD;
          -  Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids,&#xD;
             for the currently treated gastric cancer.&#xD;
&#xD;
          -  Has uncontrolled epilepsy, central nervous system diseases or mental disorders of&#xD;
             history.&#xD;
&#xD;
          -  Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery&#xD;
             disease, New York Heart Association (NYHA) grade II or greater congestive heart&#xD;
             failure or serious cardiac arrhythmia requiring medication or myocardial infarction&#xD;
             within the last 12 months.&#xD;
&#xD;
          -  Lack of physical integrity of the upper gastrointestinal tract or those who have&#xD;
             malabsorption syndrome likely to influence absorption of capecitabine, or inability to&#xD;
             take oral medication.&#xD;
&#xD;
          -  Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events).&#xD;
             Absence of deep tendon reflexes as the sole neurologic abnormality does not render the&#xD;
             patient ineligible.&#xD;
&#xD;
          -  Organ allografts requiring immunosuppressive therapy.&#xD;
&#xD;
          -  Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant&#xD;
             disease.&#xD;
&#xD;
          -  Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min&#xD;
             (calculated according to Cockroft and Gault)], or serum creatinine &gt; 1.5 x upper limit&#xD;
             of normal (ULN).&#xD;
&#xD;
          -  Any of the following laboratory values:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) &lt; 1.5 x 109/L&#xD;
&#xD;
               -  Platelet count &lt; 100 x 109/L&#xD;
&#xD;
               -  Total bilirubin &gt; 1.5 x ULN&#xD;
&#xD;
               -  ALAT, ASAT &gt; 2.5 x ULN&#xD;
&#xD;
               -  Alkaline phosphatase &gt; 2.5 x ULN.&#xD;
&#xD;
          -  Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without&#xD;
             documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known&#xD;
             DPD deficiency.&#xD;
&#xD;
          -  Hypersensitivity to platinum compounds or any of the components of the study&#xD;
             medications.&#xD;
&#xD;
          -  Received any investigational drug or agent/procedure, i.e. participation in another&#xD;
             trial, within 4 weeks before randomization.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingwei Xue, Phd, MD</last_name>
    <role>Study Director</role>
    <affiliation>Harbin Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yingwei Xue</investigator_full_name>
    <investigator_title>Chief of Gastrointestinal Surgery</investigator_title>
  </responsible_party>
  <keyword>xelox</keyword>
  <keyword>advanced gastric cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_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/NCT01665274
org study id: GCPCT1205/repeat
nct id: NCT01665274
lead sponsor: 
has dmc: Yes
The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative
      chemotherapy is superior or not to operation directly for locally advanced gastric cancer in
      terms of 3 year disease-free survival (DFS) rate.
The patients of gastric cancer have been divided into two parts in random.The test group
      receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the
      same program after operation. The two groups have the same staging and eligibility
      criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate
      maybe the last evaluation standard.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 3-year DFS
time frame: 3 years after surgery
measure: adverse events
time frame: From date of randomization until the end of the study, assessed up to 5 years
measure: response rate
time frame: evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy
measure: R0 resection rate
time frame: after the pathological examination of resected speciments ie within 1 month after the operation
measure: overall survival
time frame: 5 years after surgery
arm group label: XELOX adjuvant group
arm group type: Active Comparator
description: D2 resection
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles
arm group label: XELOX neoadjuvant
arm group type: Experimental
description: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.
D2 resection
After operation:
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
arm group label: XELOX adjuvant group
arm group label: XELOX neoadjuvant
other name: xeloda
intervention type: Drug
intervention name: Oxaliplatin
description: Oxaliplatin IV infusion, 130mg/m² d1, q3w
arm group label: XELOX adjuvant group
arm group label: XELOX neoadjuvant
other name: eloxatin
intervention type: Procedure
intervention name: D2 resection
description: D2 resection
arm group label: XELOX adjuvant group
arm group label: XELOX neoadjuvant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yingwei Xue, Phd, MD
role: Study Director
affiliation: Harbin Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yingwei Xue
investigator title: Chief of Gastrointestinal Surgery
mesh term: Stomach Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin