<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/NCT04416854</url>
  </required_header>
  <id_info>
    <org_study_id>FDPRMCC</org_study_id>
    <nct_id>NCT04416854</nct_id>
  </id_info>
  <brief_title>The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer</brief_title>
  <official_title>The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this trial is to evaluate the value of palliative primary tumor resection in colon&#xD;
      cancer patients with initially unresectable metastases and a positive response to induction&#xD;
      chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall&#xD;
      survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5-year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival 1</measure>
    <time_frame>3-year</time_frame>
    <description>The first progression time after diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival 2</measure>
    <time_frame>3-year</time_frame>
    <description>The first progression time after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of adverse events resulted from chemotherapy</measure>
    <time_frame>3-year</time_frame>
    <description>The ratio of the number of patients experienced adverse events to the total patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quality of life postoperatively</measure>
    <time_frame>3-month, 6-month, 9-month, 12-month, 18-month, 24-month</time_frame>
    <description>The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>1-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of postoperative complications</measure>
    <time_frame>1-year</time_frame>
    <description>The ratio of the number of patients with postoperative complications to the total patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of surgical intervention in control group</measure>
    <time_frame>1-year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">627</enrollment>
  <condition>Metastatic Colon Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Chemotherapy plus surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>resection of primary tumor</intervention_name>
    <description>resection of primary lesion with unresectablely metastatic colon cancer</description>
    <arm_group_label>Chemotherapy plus surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>XELOX</intervention_name>
    <description>Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle</description>
    <arm_group_label>Chemotherapy alone</arm_group_label>
    <arm_group_label>Chemotherapy plus surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mFOLFOX6</intervention_name>
    <description>Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1</description>
    <arm_group_label>Chemotherapy alone</arm_group_label>
    <arm_group_label>Chemotherapy plus surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  75 years old&#xD;
&#xD;
          -  ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6&#xD;
             months or more&#xD;
&#xD;
          -  Pathological diagnosis of colon cancer adenocarcinoma&#xD;
&#xD;
          -  At least one measurable objective tumor lesions which could be evaluated.&#xD;
&#xD;
          -  Primary and metastatic tumors exist at the same time, and distant metastases are not&#xD;
             resectable&#xD;
&#xD;
          -  ANC≥1.5*109/L；PLT≥90*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening&#xD;
             within 7 days&#xD;
&#xD;
          -  No systemic chemotherapy&#xD;
&#xD;
          -  Patients with voluntary participation, and sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Operation intervention required for perforation, bleeding and obstruction of&#xD;
             intestinal cavity&#xD;
&#xD;
          -  Multiple primary colorectal carcinoma&#xD;
&#xD;
          -  Malignant peritoneal effusion or metastatic carcinoma of the peritoneum&#xD;
&#xD;
          -  Uncontrolled pleural effusion&#xD;
&#xD;
          -  Malignant tumour of the past five years with other organizations to source, but the&#xD;
             full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and&#xD;
             squamous cell carcinomas&#xD;
&#xD;
          -  With brain metastasis or meningeal metastasis&#xD;
&#xD;
          -  Pregnancy or breast-feeding women&#xD;
&#xD;
          -  Alcohol or drug addictions&#xD;
&#xD;
          -  There is an important organ failure or other serious diseases, including coronary&#xD;
             artery disease, symptomatic cardiovascular disease or myocardial infarction within 12&#xD;
             months; serious neurological or psychiatric history; severe infection; actively&#xD;
             disseminated vascula blood coagulation&#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_contact>
    <last_name>Xinxiang Li</last_name>
    <phone>+8613761291659</phone>
    <email>1149lxx@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qingguo Li</last_name>
    <phone>+8618918298120</phone>
    <email>qingguoli@fudan.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinxiang Li, MD,PhD</last_name>
      <phone>+8613918176716</phone>
      <email>lxx1149@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Qingguo Li, MD,PhD</last_name>
      <phone>+8618918298120</phone>
      <email>qingguoli@fudan.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Xinxiang Li, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>LI XIN-XIANG</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>palliative surgery</keyword>
  <keyword>stage IV colon cancer</keyword>
  <keyword>chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT04416854
org study id: FDPRMCC
nct id: NCT04416854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this trial is to evaluate the value of palliative primary tumor resection in colon
      cancer patients with initially unresectable metastases and a positive response to induction
      chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall
      survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 5-year
measure: Progression-free survival 1
time frame: 3-year
description: The first progression time after diagnosis
measure: Progression-free survival 2
time frame: 3-year
description: The first progression time after randomization
measure: The rate of adverse events resulted from chemotherapy
time frame: 3-year
description: The ratio of the number of patients experienced adverse events to the total patients
measure: The quality of life postoperatively
time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month
description: The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
measure: Objective response rate
time frame: 1-year
measure: The rate of postoperative complications
time frame: 1-year
description: The ratio of the number of patients with postoperative complications to the total patients
measure: The proportion of surgical intervention in control group
time frame: 1-year
arm group label: Chemotherapy plus surgery
arm group type: Experimental
description: Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
arm group label: Chemotherapy alone
arm group type: Active Comparator
description: Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
intervention type: Procedure
intervention name: resection of primary tumor
description: resection of primary lesion with unresectablely metastatic colon cancer
arm group label: Chemotherapy plus surgery
intervention type: Drug
intervention name: XELOX
description: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
arm group label: Chemotherapy alone
arm group label: Chemotherapy plus surgery
intervention type: Drug
intervention name: mFOLFOX6
description: Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
arm group label: Chemotherapy alone
arm group label: Chemotherapy plus surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xinxiang Li
phone: +8613761291659
email: 1149lxx@sina.com
last name: Qingguo Li
phone: +8618918298120
email: qingguoli@fudan.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: LI XIN-XIANG
investigator title: Professor
mesh term: Colonic Neoplasms