NCT03584711

FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

A Phase II Study Evaluating FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.

Detailed description

The purpose of the OPTIPRIME phase II non-randomised study is to evaluate the efficacy and tolerability of the combination of FOLFOX plus panitumumab according to a "stop and go" strategy. If disease control is achieved while on induction treatment, oxaliplatin and panitumumab will be stopped after the sixth cycle; a maintenance treatment of fluoropyrimidine alone will be continued. In case of progression during maintenance treatment, oxaliplatin and panitumumab reintroduction loops will take place according to the same regimen (maintenance treatment after six cycles of the reintroduced therapy if disease control is achieved).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	FOLFOX + panitumumab	FOLFOX + panitumumab according to a "stop and go" strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment

Timeline

• Start date: 2018-04-26
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2018-07-12
• Last updated: 2025-06-29

Locations

124 sites across 2 countries: France, Martinique