Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Chemotherapy Effect; Metastatic Colorectal Cancer
• Interventions: Drug: the rechallenge regimen

• Registration Number: NCT03485027
• Lead Sponsor: Fudan University

Brief Summary

This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.

Detailed Description

The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.

Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-24
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Primary Completion: 2022-12-24
• Study Completion: 2023-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The rechallenge regimens	the rechallenge regimen	XELOX ± BEV, repeating every 3 weeks. FOLFOX ± BEV, repeating every 2 week FOLFOX ± Cetuximab, repeating every 2 week FOLFIRI ± BEV, repeating every 2 weeks. FOLFIRI ± Cetuximab, repeating every 2 weeks. IRI ± BEV, repeating every 2 weeks. IRI ± Cetuximab, repeating every 2 weeks. Raltitrexed ± BEV, repeating every 3 weeks. Raltitrexed ± Cetuximab, repeating every 2 weeks.

Primary Outcome Measures

Name	Time	Method
PFS	from the time signing of informed consent form(ICF) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months	progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	from the time signing of ICF until the date of death from any cause, assessed up to 48 months	overall survival

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China