GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases.

ABSTRACT:

Background

The French PRODIGE 7 trial, published on January 2021, has raised doubts about the specific survival benefit provided by HIPEC with oxaliplatin 460 mg/m² (30 minutes) for the treatment of peritoneal metastases from colorectal cancer. However, several methodological flaws have been identified in PRODIGE 7, specially the HIPEC protocol or the choice of overall survival as the main endpoint, so its results have not been assumed as definitive, emphasizing the need for further research on HIPEC. It seems that the HIPEC protocol with high-dose mytomicin-C (35 mg/m²) is the preferred regime to evaluate in future clinical studies.

Methods

GECOP-MMC is a prospective, open-label, randomized, multicenter phase IV clinical trial that aims to evaluate the

SUBMITTER: Pereira F 

PROVIDER: S-EPMC9097342 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature