1,075
Participants
Start Date
November 26, 2021
Primary Completion Date
August 31, 2027
Study Completion Date
August 31, 2027
Induction chemotherapy - modified FOLFIRINOX regimen
An induction chemotherapy (6 cycles) combining irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, elvorin 200 mg/m2 followed by a 46-hour continuous infusion 2,400 mg/m2) will be delivered every 15 days (D1=D15).
Early tumor response evaluation by MRI volumetry
Two weeks after the CT completion, the tumor volume will be measured by MRI with specific software which automatically borders the tumor so as to determine the early tumor response. A centralized reassessment of all MRI exams will be systematically performed by two radiologists of the coordinator center.
Radiochemotherapy Cap 50
RCT Cap 50 will combine radiotherapy at a dose of 50 Gy by either conventional 3D or Intensity-Modulated RadioTherapy (IMRT) (2 Gy per fraction, 5 fractions per week during 5 weeks / 44 Gy in mini pelvis, and boost 6 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of radiotherapy treatment (2 daily intake).
Radical proctectomy with total mesorectal excision
The proctectomy can be performed by laparoscopic surgery or conventional laparotomy.
RECRUITING
Hôpital Européen de MARSEILLE, Marseille
RECRUITING
Hôpital La Timone, Marseille
NOT_YET_RECRUITING
Hôpital Nord de Marseille, Marseille
NOT_YET_RECRUITING
Centre Georges-François Leclerc, Dijon
RECRUITING
CHU Besançon, Besançon
RECRUITING
CHU de Nîmes, Nîmes
RECRUITING
CHU de Toulouse, Toulouse
RECRUITING
Bordeaux Colorectal Institute, Bordeaux
RECRUITING
CHU de Bordeaux, Bordeaux
RECRUITING
Insitut Régional du Cancer de Montpellier, Montpellier
RECRUITING
Institut de Cancérologie de l'Ouest, Saint-Herblain
RECRUITING
CHU de Nancy, Vandœuvre-lès-Nancy
RECRUITING
Centre Alexis Vautrin, Nancy
RECRUITING
Centre Oscart Lambret, Lille
RECRUITING
Chu Lille, Lille
RECRUITING
CHU Clermont-Ferrand, Clermont-Ferrand
RECRUITING
CH PAU, Pau
RECRUITING
CHU de Lyon, Lyon
NOT_YET_RECRUITING
Ch Annecy, Annecy
RECRUITING
Hôpital Saint-Louis, Paris
RECRUITING
Hôpital Saint-Antoine, Paris
RECRUITING
Hôpital Européen Georges-Pompidou, Paris
RECRUITING
Hôpital Diaconesses, Paris
RECRUITING
CHU Rouen, Rouen
RECRUITING
CHU Amiens, Amiens
RECRUITING
Hôpital Bicêtre, Le Kremlin-Bicêtre
RECRUITING
Chu Grenoble, Grenoble
RECRUITING
CAC Léon Bérard, Lyon
RECRUITING
Centre Antoine Lacassagne, Nice
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER