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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Colorectal Cancer Adjuvant Chemotherapy Behavioral: wait and watch Drug: adjuvant chemotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 30, 2019
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2026

Resource links provided by the National Library of Medicine


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 Name: mFOLFOX6




Primary Outcome Measures :
  1. disease free survival [ Time Frame: 3years ]
    3years disease-free survival rate


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5years ]
    5years overall survival rate

  2. adverse reaction of adjuvant therapies [ Time Frame: 3years ]
    Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair

  3. remission rate of adjuvant therapies [ Time Frame: 1year ]
    CRC remission evaluation using RECIST after adjuvant therapies

  4. death rate within 30 days post surgery [ Time Frame: 30days ]
    death related directly with operation within 30 days

  5. complication in 30 days post surgery [ Time Frame: 30days ]
    Rate of participants with complications such as bleeding,infection,anastomotic fistula,etc



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748485


Contacts
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Contact: Jianping Wang, MD/PHD +86 13808874808 wangjpgz@126.com
Contact: Jun Huang, MD/PHD +86 13926451242 haungj97@mail.sysu.edu.cn

Locations
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China, Guangdong
Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Jun Huang, M.D.    +8613926451242    huangj97@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Chair: Jianping Wang, MD/PHD sixth affiliate hospital of Sun yatsen Hospital
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Responsible Party: Jianping Wang, professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03748485    
Other Study ID Numbers: L2018ZSLYEC-162
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianping Wang, Sixth Affiliated Hospital, Sun Yat-sen University:
local advanced colorectal cancer
adjuvant chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases