De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 1, 2031

Study Completion Date

January 1, 2031

Conditions
Metastatic Colon Cancer
Interventions
DRUG

treatment adaptation guided by ctDNA variation

"after 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3: Arm A1: CT discontinuation (ctDNA normalization \< 0.1 ng/ml or ctDNA not detectable) Arm A2 : maintenance with fluoropyrimidine + TA (ctDNA ≥ 0.1 ng/ml and ∆ctDNA≥ 80%).~Arm A3 : ctDNA non-responders (∆ctDNA \< 80% or increase) : switch of CT +/- TA."

DRUG

standard management

At least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.

All Listed Sponsors
lead

University Hospital, Rouen

OTHER