58
Participants
Start Date
July 8, 2019
Primary Completion Date
June 30, 2024
Study Completion Date
December 31, 2027
Chemotherapy FOLFIRINOX, 6 cycles
"* oxaliplatin: 85 mg/m2~* irinotecan: 180 mg/m²~* folinic acid: 400 mg/m2~* 5FU : 400 mg/m2 (bolus)~* 5FU : 2400 mg/m2 (continuous infusion)"
Radiochemotherapy
Reirradiation consists in conformational intensity modulated external irradiation (Intensity-modulated radiotherapy Volumetric Modulated Arc Therapy or tomotherapy) delivering a 30.6 Gy dose with high-energy photons in fractions of 1.8 Gy per day (17 fractions) 5 days a week With Concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week.
Surgery
"Surgery will be performed at:~* Arm A: 8 weeks (±1) after the end of treatment~* Arm B: 6 weeks (±1) after the end of treatment~Surgical procedures are defined into three categories:~* Total mesorectal excision (TME)~* Extended-TEM (e-TME)~* Pelvic exenteration (PE)"
Institut Sainte Catherine, Avignon
CHU Bordeaux, Bordeaux
CHU Grenoble, Grenoble
Centre Oscar Lambret, Lille
Hospices Civils de Lyon, HCL, Lyon
Institut Paoli Calmette, Marseille
Institut du Cancer de Montpellier, Montpellier
CHRU Nancy, Nancy
Groupe Hospitalier Paris Saint-Joseph, Paris
CHU Rennes, Rennes
CHU Rouen, Rouen
Institut de Cancérologie de l'Ouest, Saint-Herblain
CHU Toulouse, Toulouse
University Hospital, Bordeaux
OTHER