drugset / Trial / NCT03879109

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

NCT03879109 ↗

Phase 3 Completed 58 enrolled University Hospital, Bordeaux
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-07-08
Primary completion
2024-06-30
Completion
2026-02-10

Drugs

EvaluationDrugModalityDoseRoute
Background Irinotecan Small molecule 180 mg/m2 —
Background Leucovorin Small molecule 400 mg/m2 —
Background Oxaliplatin Small molecule 85 mg/m2 —
Background fluorouracil Small molecule 400 mg/m2 —
Background fluorouracil Small molecule 2400 mg/m2 —

Indications