Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

446

Participants

Timeline

Start Date

May 9, 2023

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2030

Conditions
Metastatic Colorectal Cancer
Interventions
OTHER

quality of life questionnaires

EORTC QLQ-C30 questionnaire (Quality of life questionnaire- Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D3L questionnaire (EuroQol-5 Dimensions, 3 levels)

PROCEDURE

Blood sample

Blood sample for plasma collection Blood sample for ctDNA (circulating tumoral DNA) collection

DRUG

Regorafenib

"\- Regorafenib will be administered 3 weeks out of 4 for two months or unacceptable toxicity.~* For the first cycle: regorafenib will be administered according to the REDOS schedule (80 mg daily for week 1, 120 mg daily for week 2 and 160 mg daily for the third week of the first cycle).~* For the second cycle: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle."

DRUG

Metronomic chemotherapies

"* Capecitabine: 625mg/m²/orally twice daily continuously during the first two months~* Cyclophosphamide: 50 mg per os, daily, for two months"

DRUG

Aspirin

75 mg orally and daily during two months

DRUG

Bevacizumab

5 mg/Kg every 2 weeks according to investigator practice, until disease progression or unacceptable toxicity

DRUG

FOLFIRI or FOLFOX

every 2 weeks according to investigator practice

Trial Locations (16)

69000

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

Unknown

RECRUITING

CHU de Besançon, Besançon

NOT_YET_RECRUITING

CHU Estain, Clermont-Ferrand

RECRUITING

Hôpital Henri Mondor, Créteil

RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

Hôpital Privé Jean Mermoz, Lyon

RECRUITING

Hôpital Nord Franche Comté, Montbéliard

RECRUITING

CHU Montpellier, Montpellier

RECRUITING

Groupe hospitalier de la région de Mulhouse et Sud Alsace, Mulhouse

NOT_YET_RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

Hôpital Européen Georges Pompidou, Paris

RECRUITING

Hôpital la Pitié-Salpétrière, Paris

RECRUITING

Hôpital Saint antoine, Paris

RECRUITING

Institut Mutualiste Montsouris, Paris

RECRUITING

CHU de Reims - Hôpital Robert Debré, Reims

NOT_YET_RECRUITING

Hôpital FOCH, Suresnes

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER