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Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer
Sponsor: University Hospital, Bordeaux
Summary
GRECCAR 15 is focused on Locally Recurrent Rectal Cancer (LRRC) for patients with previous pelvic radiotherapy for the primary rectal cancer. This situation leads to a 20% higher risk of non-curative resection for the LRRC management (R1 status) impacting significantly the overall survival. The widespread use of neoadjuvant radiotherapy for primary rectal cancer introduces this new problem: the treatment of LRRC in previously irradiated area. The objective of GRECCAR 15 is to assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC.
Official title: A Phase III Randomized Trial Evaluating Chemotherapy Followed by Pelvic Reirradiation Versus Chemotherapy Alone as Pre-operative Treatment for Locally Recurrent Rectal Cancer (GRECCAR - PRODIGE - FRENCH)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2019-07-08
Completion Date
2027-12
Last Updated
2024-08-14
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (13)
Institut Sainte Catherine
Avignon, France
CHU Bordeaux
Bordeaux, France
CHU Grenoble
Grenoble, France
Centre Oscar Lambret
Lille, France
Hospices Civils de Lyon, HCL
Lyon, France
Institut Paoli Calmette
Marseille, France
Institut du Cancer de Montpellier
Montpellier, France
CHRU Nancy
Nancy, France
Groupe Hospitalier Paris Saint-Joseph
Paris, France
CHU Rennes
Rennes, France
CHU Rouen
Rouen, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
CHU Toulouse
Toulouse, France