<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/NCT02226380</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-JZ</org_study_id>
    <nct_id>NCT02226380</nct_id>
  </id_info>
  <brief_title>FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer</brief_title>
  <acronym>FOLFOX6</acronym>
  <official_title>A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant&#xD;
      chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a&#xD;
      series in local advanced gastric cancer patients.&#xD;
&#xD;
      Patients and methods: The study is a prospective non-randomized study. Patients with&#xD;
      histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled&#xD;
      in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2&#xD;
      lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative&#xD;
      chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with&#xD;
      postoperative pathologic staging on patients who underwent radical surgery. Tumor&#xD;
      down-staging and the grade of pathologic response are included in a statistical correlation&#xD;
      between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The&#xD;
      primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,&#xD;
      R0 resection rate, toxicity and prediction of response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen</measure>
    <time_frame>3 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The R0 resection rate in the patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen</measure>
    <time_frame>9 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Effects of Chemotherapy</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>mFOLFOX6,chemotherapy regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mFOLFOX6 regimen</intervention_name>
    <description>oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery</description>
    <arm_group_label>mFOLFOX6,chemotherapy regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligibility criteria included histologically confirmed gastric cancer, the&#xD;
        gastro-oesophageal junction(GEJ) may be involved, but the bulk of the tumour has to be in&#xD;
        the stomach; age ≥18 years old, ECOG performance status score ≤2, no prior chemotherapy,&#xD;
        TNM stage of T2-T4 or positive regional lymph nodes by endoscopic ultrasound or computed&#xD;
        tomography (CT), and adequate hematological, heart, liver and renal functions (ALT and&#xD;
        AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with second malignancies or evidence of severe or uncontrolled systemic disease&#xD;
        were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiang Wang, Master</last_name>
    <role>Study Director</role>
    <affiliation>Department of Medical Oncology Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiang Wang, Master</last_name>
    <phone>+86 (10) 6915 8315</phone>
    <email>wangxiang5123@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiang Wang, Master</last_name>
      <phone>+86(10)69158315</phone>
      <email>wangxiang5123@126.com</email>
    </contact>
    <investigator>
      <last_name>Xiao yi Li, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao yi Li, Mater</last_name>
      <phone>+86(10)69154910</phone>
      <email>li.xiaoyi@263.net</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Li ZY, Koh CE, Bu ZD, Wu AW, Zhang LH, Wu XJ, Wu Q, Zong XL, Ren H, Tang L, Zhang XP, Li JY, Hu Y, Shen L, Ji JF. Neoadjuvant chemotherapy with FOLFOX: improved outcomes in Chinese patients with locally advanced gastric cancer. J Surg Oncol. 2012 Jun 15;105(8):793-9. doi: 10.1002/jso.23009. Epub 2011 Dec 20.</citation>
    <PMID>22189752</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT02226380
org study id: PUMCH-JZ
nct id: NCT02226380
lead sponsor: 
has dmc: No
Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant
      chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a
      series in local advanced gastric cancer patients.

      Patients and methods: The study is a prospective non-randomized study. Patients with
      histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled
      in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2
      lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative
      chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with
      postoperative pathologic staging on patients who underwent radical surgery. Tumor
      down-staging and the grade of pathologic response are included in a statistical correlation
      between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The
      primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival,
      R0 resection rate, toxicity and prediction of response.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen
time frame: 3 years
measure: The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen
time frame: 3 year
measure: The R0 resection rate in the patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen
time frame: 9 weeks
arm group label: mFOLFOX6,chemotherapy regimen
arm group type: Experimental
description: oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery
intervention type: Drug
intervention name: mFOLFOX6 regimen
description: oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery
arm group label: mFOLFOX6,chemotherapy regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiang Wang, Master
role: Study Director
affiliation: Department of Medical Oncology Peking Union Medical College Hospital
last name: Xiang Wang, Master
phone: +86 (10) 6915 8315
email: wangxiang5123@126.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
citation: Li ZY, Koh CE, Bu ZD, Wu AW, Zhang LH, Wu XJ, Wu Q, Zong XL, Ren H, Tang L, Zhang XP, Li JY, Hu Y, Shen L, Ji JF. Neoadjuvant chemotherapy with FOLFOX: improved outcomes in Chinese patients with locally advanced gastric cancer. J Surg Oncol. 2012 Jun 15;105(8):793-9. doi: 10.1002/jso.23009. Epub 2011 Dec 20.
PMID: 22189752
responsible party type: Sponsor
mesh term: Stomach Neoplasms