Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB

PHASE3RecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

May 4, 2025

Study Completion Date

May 4, 2026

Conditions
Colorectal CancerMetastatic Colorectal CancerRAS Mutation
Interventions
DRUG

Bevacizumab

"This is the treatment assigned to experimental arm:~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."

DRUG

Cetuximab

"This is the treatment assigned to control arm:~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."

DRUG

5-FU

"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."

DRUG

Irinotecan

"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."

DRUG

Calcium levofolinate

"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."

Trial Locations (4)

30035

RECRUITING

Azienda ULSS 3 Serenissima, Mirano

42016

RECRUITING

Ospedale Civile di Guastalla, Guastalla

42123

RECRUITING

AUSL/IRCCS di Reggio Emilia, Reggio Emilia

67100

RECRUITING

Ospedale San Salvatore, Coppito

All Listed Sponsors
collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

NETWORK

lead

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV