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ACTIVE NOT RECRUITING
NCT03879109
PHASE3

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

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)

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