Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 8, 2019

Primary Completion Date

June 30, 2024

Study Completion Date

December 31, 2027

Conditions
Rectal Cancer
Interventions
DRUG

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)"

RADIATION

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.

PROCEDURE

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)"

Trial Locations (13)

Unknown

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

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT03879109 - Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer | Biotech Hunter | Biotech Hunter