IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

792

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)
Interventions
DRUG

Irinotecan

every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started

DRUG

Folfox Protocol

every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion

Trial Locations (17)

Unknown

The PEI Cancer Treatment Centre Queen Elizabeth Hospital, Charlottetown

Hopital Charles LeMoyne, Greenfield Park

Centre hospitalier de l'Université de Montréal, Montreal

Allan Blair Cancer Centre, Regina

Institut de Cancérologie de l'Ouest -site Paul Papin, Angers

CHD de Vendée, La Roche-sur-Yon

Ch Emile Roux, Le Puy-en-Velay

Hospices civils de Lyon - Hôpital Edouard Herriot, Lyon

Hôpital privé Jean Mermoz, Lyon

Icm Val D'Aurelle, Montpellier

Institut de Cancérologie de l'Ouest -site René Gauducheau, Nantes

Hôpital Européen Georges Pompidou, Paris

Hôpital Saint Antoine, Paris

Centre Hospitalier Annecy Genevois, Pringy

Institut Jean Godinot, Reims

CHP Saint Grégoire, Saint-Grégoire

Clinique de la Côte d'Emeraude, St-Malo

All Listed Sponsors
collaborator

Canadian Cancer Trials Group

NETWORK

collaborator

GONO GROUP

UNKNOWN

lead

UNICANCER

OTHER