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

Primary Purpose

Colorectal Cancer, Adjuvant Chemotherapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
wait and watch
adjuvant chemotherapy
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring local advanced colorectal cancer, adjuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

wait and watch group

adjuvant chemotherapy group

Arm Description

clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy

clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) with adjuvant chemotherapy

Outcomes

Primary Outcome Measures

disease free survival
3years disease-free survival rate

Secondary Outcome Measures

overall survival
5years overall survival rate
adverse reaction of adjuvant therapies
Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair
remission rate of adjuvant therapies
CRC remission evaluation using RECIST after adjuvant therapies
death rate within 30 days post surgery
death related directly with operation within 30 days
complication in 30 days post surgery
Rate of participants with complications such as bleeding,infection,anastomotic fistula,etc

Full Information

First Posted
November 15, 2018
Last Updated
January 25, 2022
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03748485
Brief Title
Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Acronym
CANWATCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adjuvant Chemotherapy
Keywords
local advanced colorectal cancer, adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
wait and watch group
Arm Type
Experimental
Arm Description
clinical local advanced colorectal cancer (cTxN1/2M0) following pre-operational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0) without adjuvant chemotherapy
Arm Title
adjuvant chemotherapy group
Arm Type
Active Comparator
Arm 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(s)
wait and watch
Intervention Description
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy
Other Intervention Name(s)
mFOLFOX6
Intervention Description
clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
Primary Outcome Measure Information:
Title
disease free survival
Description
3years disease-free survival rate
Time Frame
3years
Secondary Outcome Measure Information:
Title
overall survival
Description
5years overall survival rate
Time Frame
5years
Title
adverse reaction of adjuvant therapies
Description
Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair
Time Frame
3years
Title
remission rate of adjuvant therapies
Description
CRC remission evaluation using RECIST after adjuvant therapies
Time Frame
1year
Title
death rate within 30 days post surgery
Description
death related directly with operation within 30 days
Time Frame
30days
Title
complication in 30 days post surgery
Description
Rate of participants with complications such as bleeding,infection,anastomotic fistula,etc
Time Frame
30days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianping Wang, MD/PHD
Phone
+86 13808874808
Email
wangjpgz@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Huang, MD/PHD
Phone
+86 13926451242
Email
haungj97@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Wang, MD/PHD
Organizational Affiliation
sixth affiliate hospital of Sun yatsen Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Huang, M.D.
Phone
+8613926451242
Email
huangj97@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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