461
Participants
Start Date
January 31, 2012
Primary Completion Date
July 1, 2023
Study Completion Date
July 1, 2023
mFolfirinox
Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
Radiotherapy 50 Gy
5 radiations per week of 2 Gy for 5 weeks
Capecitabine
1600 mg/m² (800 mg/m² twice daily) for 5 weeks
TME surgery
mFolfox6 or capecitabine
oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
Centre hospitalier Universitaire d'Amiens, Amiens
ICO - Site Paul Papin, Angers
Centre hospitalier d'Auxerre, Auxerre
Centre Hospitalier de Beauvais, Beauvais
Institut de Cancérologie de Franche Comté, Besançon
Centre Hospitalier de Blois, Blois
Hopital Avicenne, Bobigny
Clinique Tivoli, Bordeaux
Hopital Saint Andre, Bordeaux
Institut Bergonie, Bordeaux
Centre Francois Baclesse, Caen
Chd de La Roche Sur Yon - Les Oudairies, La Roche-sur-Yon
Centre Bourgogne, Lille
Centre Oscar Lambret, Lille
Centre Léon Bérard, Lyon
Hopital Prive Jean Mermoz, Lyon
Ap Hm - Hopital de La Timone - Adultes, Marseille
Institut de Cancérologie de Franche Comté, Montbéliard
Centre Azuréen de cancérologie, Mougins
Hopital Emile Muller, Mulhouse
centre Alexis Vautrin, Nancy
Polyclinique de Gentilly, Nancy
Centre Antoine Lacassagne, Nice
Groupe Hospitalier La Pitie-Salpetriere, Paris
Institut Mutualiste Montsouris, Paris
Hopital Haut Leveque, Pessac
Centre Hospitalier Regional D'Annecy, Pringy
Hopital Robert Debre, Reims
Institut Jean Godinot, Reims
Clinique Armoricaine de Radiologie, Saint-Brieuc
Hopital Saint Gregoire, Saint-Grégoire
ICO - Site René Gauducheau, Saint-Herblain
Clinique Mutualiste de L'Estuaire, Saint-Nazaire
Centre Hospitalier de la Réunion - Site du GHSR, Saint-Pierre
Centre Paul Strauss, Strasbourg
Gustave Roussy, Villejuif
UNICANCER
OTHER