Clincosm LogoSign in Get a demo

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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03748485
Collaborator
(none)
650
Enrollment
1
Location
2
Arms
92
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: wait and watch
  • Drug: adjuvant chemotherapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
650 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 30, 2019
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2026

Arms and Interventions

Arm Intervention/Treatment
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

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
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

Drug: adjuvant chemotherapy
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
Other Names:
  • mFOLFOX6

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease free survival [3years]

      3years disease-free survival rate

    Secondary Outcome Measures

    1. overall survival [5years]

      5years overall survival rate

    2. adverse reaction of adjuvant therapies [3years]

      Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair

    3. remission rate of adjuvant therapies [1year]

      CRC remission evaluation using RECIST after adjuvant therapies

    4. death rate within 30 days post surgery [30days]

      death related directly with operation within 30 days

    5. complication in 30 days post surgery [30days]

      Rate of participants with complications such as bleeding，infection，anastomotic fistula,etc

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510655

    Sponsors and Collaborators

    • Sixth Affiliated Hospital, Sun Yat-sen University

    Investigators

    • Study Chair: Jianping Wang, MD/PHD, sixth affiliate hospital of Sun yatsen Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianping Wang, professor, Sixth Affiliated Hospital, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03748485
    Other Study ID Numbers:
    • L2018ZSLYEC-162
    First Posted:
    Nov 21, 2018
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jianping Wang, professor, Sixth Affiliated Hospital, Sun Yat-sen University
    local advanced colorectal cancer
    adjuvant chemotherapy
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Jan 26, 2022