<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/NCT03748485</url>
  </required_header>
  <id_info>
    <org_study_id>L2018ZSLYEC-162</org_study_id>
    <nct_id>NCT03748485</nct_id>
  </id_info>
  <brief_title>Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis</brief_title>
  <acronym>CANWATCH</acronym>
  <official_title>Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1/2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following&#xD;
      initial treatment of surgery without high risk factors of recurrences. The treatment efficacy&#xD;
      of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational&#xD;
      chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal&#xD;
      cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or&#xD;
      chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy&#xD;
      of the preoperational treatments, or the misleading by lymph nodes false-positive imaging&#xD;
      diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer(CRC) nowadays rank the 3rd incidence and the 4th mortality in all cancers&#xD;
      worldwide(ref). Although the coloscopy or liquid biopsy screen has improved the early&#xD;
      diagnosis of CRC, about 26.5-36.0% of the patients were diagnosed local advanced CRC at the&#xD;
      first visit. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to&#xD;
      be pT1-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need&#xD;
      adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the&#xD;
      misleading by lymph nodes false-positive imaging diagnosis. Adjuvant chemotherapy was been&#xD;
      admitted unnecessary in the pathological stage ⅡA (pT0-3N0M0) CRC following initial treatment&#xD;
      of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant&#xD;
      chemotherapy for pT1-3N0M0 CRC following preoperational chemotherapy or chemoradiotherapy&#xD;
      remains unclear. The aim of this study is to evaluate the efficacy/safety of adjuvant&#xD;
      chemotherapy in clinical local advanced CRC (cTxN1/2M0) following preoperational adjuvant&#xD;
      therapies and pathologically proved pT0-3N0M0 CRC. Patients are randomized to control&#xD;
      group(down-staged pT0-3N0M0 CRC with 6 to 8 periods adjuvant chemotherapy) and experimental&#xD;
      group(watch group, down-staged pT0-3N0M0 CRC without adjuvant chemotherapy). The primary&#xD;
      endpoint is the 3-years disease-free survival after surgery. Secondary endpoints evaluate&#xD;
      long-term clinical outcomes, in particular overall survival and side effect of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease free survival</measure>
    <time_frame>3years</time_frame>
    <description>3years disease-free survival rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5years</time_frame>
    <description>5years overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse reaction of adjuvant therapies</measure>
    <time_frame>3years</time_frame>
    <description>Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>remission rate of adjuvant therapies</measure>
    <time_frame>1year</time_frame>
    <description>CRC remission evaluation using RECIST after adjuvant therapies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death rate within 30 days post surgery</measure>
    <time_frame>30days</time_frame>
    <description>death related directly with operation within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication in 30 days post surgery</measure>
    <time_frame>30days</time_frame>
    <description>Rate of participants with complications such as bleeding，infection，anastomotic fistula,etc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">650</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Adjuvant Chemotherapy</condition>
  <arm_group>
    <arm_group_label>wait and watch group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>adjuvant chemotherapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) with adjuvant chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>wait and watch</intervention_name>
    <description>clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy</description>
    <arm_group_label>wait and watch group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>adjuvant chemotherapy</intervention_name>
    <description>clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy</description>
    <arm_group_label>adjuvant chemotherapy group</arm_group_label>
    <other_name>mFOLFOX6</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preoperative clinical tumor stage III （TxN1-2M0）CRC&#xD;
&#xD;
          -  pathological proved CRC adenocarcinoma by endoscopic biopsy&#xD;
&#xD;
          -  Post operational pathological T0-3N0M0 without high risk factors of recurrence&#xD;
&#xD;
          -  Patient able to understand and sign written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other malignant tumors history.&#xD;
&#xD;
          -  Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and&#xD;
             abscesses).&#xD;
&#xD;
          -  Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver&#xD;
             R0 resection impossible immediately.&#xD;
&#xD;
          -  Non resectable lymph node metastasis.&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative&#xD;
             Oncology Group(ECOG) score≥ 2.&#xD;
&#xD;
          -  Physical or psychological dependence.&#xD;
&#xD;
          -  Pregnant or breast feeding women.&#xD;
&#xD;
          -  Not controlled pre-operational infection.&#xD;
&#xD;
          -  Enrolled in other clinical trials within 4 weeks.&#xD;
&#xD;
          -  Other clinical or laboratorial condition not recommended by investigators.&#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>Jianping Wang, MD/PHD</last_name>
    <role>Study Chair</role>
    <affiliation>sixth affiliate hospital of Sun yatsen Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianping Wang, MD/PHD</last_name>
    <phone>+86 13808874808</phone>
    <email>wangjpgz@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jun Huang, MD/PHD</last_name>
    <phone>+86 13926451242</phone>
    <email>haungj97@mail.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Huang, M.D.</last_name>
      <phone>+8613926451242</phone>
      <email>huangj97@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>January 25, 2022</last_update_submitted>
  <last_update_submitted_qc>January 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jianping Wang</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>local advanced colorectal cancer</keyword>
  <keyword>adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03748485
org study id: L2018ZSLYEC-162
nct id: NCT03748485
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following
      initial treatment of surgery without high risk factors of recurrences. The treatment efficacy
      of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational
      chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal
      cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or
      chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy
      of the preoperational treatments, or the misleading by lymph nodes false-positive imaging
      diagnosis.
Colorectal cancer(CRC) nowadays rank the 3rd incidence and the 4th mortality in all cancers
      worldwide(ref). Although the coloscopy or liquid biopsy screen has improved the early
      diagnosis of CRC, about 26.5-36.0% of the patients were diagnosed local advanced CRC at the
      first visit. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to
      be pT1-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need
      adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the
      misleading by lymph nodes false-positive imaging diagnosis. Adjuvant chemotherapy was been
      admitted unnecessary in the pathological stage ⅡA (pT0-3N0M0) CRC following initial treatment
      of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant
      chemotherapy for pT1-3N0M0 CRC following preoperational chemotherapy or chemoradiotherapy
      remains unclear. The aim of this study is to evaluate the efficacy/safety of adjuvant
      chemotherapy in clinical local advanced CRC (cTxN1/2M0) following preoperational adjuvant
      therapies and pathologically proved pT0-3N0M0 CRC. Patients are randomized to control
      group(down-staged pT0-3N0M0 CRC with 6 to 8 periods adjuvant chemotherapy) and experimental
      group(watch group, down-staged pT0-3N0M0 CRC without adjuvant chemotherapy). The primary
      endpoint is the 3-years disease-free survival after surgery. Secondary endpoints evaluate
      long-term clinical outcomes, in particular overall survival and side effect of chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: disease free survival
time frame: 3years
description: 3years disease-free survival rate
measure: overall survival
time frame: 5years
description: 5years overall survival rate
measure: adverse reaction of adjuvant therapies
time frame: 3years
description: Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair
measure: remission rate of adjuvant therapies
time frame: 1year
description: CRC remission evaluation using RECIST after adjuvant therapies
measure: death rate within 30 days post surgery
time frame: 30days
description: death related directly with operation within 30 days
measure: complication in 30 days post surgery
time frame: 30days
description: Rate of participants with complications such as bleeding，infection，anastomotic fistula,etc
arm group label: wait and watch group
arm group type: Experimental
description: clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy
arm group label: adjuvant chemotherapy group
arm group type: Active Comparator
description: clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) with adjuvant chemotherapy
intervention type: Behavioral
intervention name: wait and watch
description: clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy
arm group label: wait and watch group
intervention type: Drug
intervention name: adjuvant chemotherapy
description: clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
arm group label: adjuvant chemotherapy group
other name: mFOLFOX6
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianping Wang, MD/PHD
role: Study Chair
affiliation: sixth affiliate hospital of Sun yatsen Hospital
last name: Jianping Wang, MD/PHD
phone: +86 13808874808
email: wangjpgz@126.com
last name: Jun Huang, MD/PHD
phone: +86 13926451242
email: haungj97@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: Jianping Wang
investigator title: professor
mesh term: Colorectal Neoplasms
sharing ipd: No