Last updated on July 2019

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

Brief description of study

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

Detailed Study 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).

Clinical Study Identifier: NCT03584711

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