mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

Phase 2

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: mFOLFOXIRI; Drug: mFOLFOX6 OR CapeOx

• Registration Number: NCT05200299
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief Summary

This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

Detailed Description

This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as adjuvant chemotherapy.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Last Update Submitted: 2022-01-18
• Study First Posted: 2022-01-20
• Last Update Posted: 2022-01-20
• Study Start: 2022-02-01
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-75 years
• ECOG PS 0-1
• Curative surgery (R0 resection)
• ypStage III B and ypStage III C
• No distant metastasis after surgery

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Exclusion Criteria

• any treatment before surgery including chemotherapy, radiotherapy and targeted agents.
• Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
• Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
• Heart failure grade III/IV (NYHA-classification).
• Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
• Subjects with known allergy to the study drugs or to any of its excipients.
• Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
• Breast- feeding or pregnant women
• Lack of effective contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFOXIRI adjuvant chemotherapy	mFOLFOXIRI	Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.
mFOLFOXIRI adjuvant chemotherapy	mFOLFOX6 OR CapeOx	Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.
mFOLFOX6 or CapeOx adjuvant chemotherapy	mFOLFOX6 OR CapeOx	Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.

Primary Outcome Measures

Name	Time	Method
2-year Disease-free survival	up to 2 years	Defined as the time from randomization to relapse or death, whichever occurred first

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years	Defined as the time from randomization to death from any cause
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.	up to 3 years	Safety
QLQ-C30 Quality of Life questionnaire	up to 3 years	postoperative quality of life
Quality of Life assessed by SF-36	up to 3 years	postoperative quality of life

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China