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Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis (CANWATCH)

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ClinicalTrials.gov Identifier: NCT03748485
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jianping Wang, Sixth Affiliated Hospital, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE April 30, 2019
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
disease free survival [ Time Frame: 3years ]
3years disease-free survival rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2018)
  • overall survival [ Time Frame: 5years ]
    5years overall survival rate
  • adverse reaction of adjuvant therapies [ Time Frame: 3years ]
    Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair
  • remission rate of adjuvant therapies [ Time Frame: 1year ]
    CRC remission evaluation using RECIST after adjuvant therapies
  • death rate within 30 days post surgery [ Time Frame: 30days ]
    death related directly with operation within 30 days
  • complication in 30 days post surgery [ Time Frame: 30days ]
    Rate of participants with complications such as bleeding,infection,anastomotic fistula,etc
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Adjuvant Chemotherapy
Intervention  ICMJE
  • Behavioral: wait and watch
    clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy
  • Drug: adjuvant chemotherapy
    clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
    Other Name: mFOLFOX6
Study Arms  ICMJE
  • Experimental: wait and watch group
    clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy
    Intervention: Behavioral: wait and watch
  • Active Comparator: adjuvant chemotherapy group
    clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) with adjuvant chemotherapy
    Intervention: Drug: adjuvant chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2018)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2026
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • preoperative clinical tumor stage III (TxN1-2M0)CRC
  • pathological proved CRC adenocarcinoma by endoscopic biopsy
  • Post operational pathological T0-3N0M0 without high risk factors of recurrence
  • Patient able to understand and sign written informed consent

Exclusion Criteria:

  • Other malignant tumors history.
  • Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).
  • Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
  • Non resectable lymph node metastasis.
  • American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2.
  • Physical or psychological dependence.
  • Pregnant or breast feeding women.
  • Not controlled pre-operational infection.
  • Enrolled in other clinical trials within 4 weeks.
  • Other clinical or laboratorial condition not recommended by investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianping Wang, MD/PHD +86 13808874808 wangjpgz@126.com
Contact: Jun Huang, MD/PHD +86 13926451242 haungj97@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03748485
Other Study ID Numbers  ICMJE L2018ZSLYEC-162
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jianping Wang, Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor  ICMJE Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jianping Wang, MD/PHD sixth affiliate hospital of Sun yatsen Hospital
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP