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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Adjuvant Chemotherapy
• Intervention / Treatment: Behavioral: wait and watch; Drug: adjuvant chemotherapy

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: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianping Wang, MD/PHD; Phone Number: +86 13808874808; Email: wangjpgz@126.com
• Study Contact Backup: Name: Jun Huang, MD/PHD; Phone Number: +86 13926451242; Email: haungj97@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Jun Huang, M.D.; Phone Number: +8613926451242; Email: huangj97@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	3years disease-free survival rate	3years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	5years overall survival rate	5years
adverse reaction of adjuvant therapies	Rate of participants with myelosuppression, gastrointestinal reaction, infection, lose hair	3years
remission rate of adjuvant therapies	CRC remission evaluation using RECIST after adjuvant therapies	1year
death rate within 30 days post surgery	death related directly with operation within 30 days	30days
complication in 30 days post surgery	Rate of participants with complications such as bleeding，infection，anastomotic fistula,etc	30days

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Jianping Wang, MD/PHD, sixth affiliate hospital of Sun yatsen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 17, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: adjuvant chemotherapy; local advanced colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: L2018ZSLYEC-162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No