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The main funding for the GECOP-MMC trial comes from the research funds of the Hospital Universitario de Fuenlabrada (Madrid, Spain), which is the main sponsor (Contact information: Paz Iglesias, Head of Research Area,mariapaz.iglesias@salud.madrid.org).Additional funding has been obtained from the Sociedad Espanola de Oncologia Quirurgica's own funds and through a research grant for multicenter studies from the Asociacion Espanola de Cirujanos. None of the funding sources have played a role in designing the study, nor influenced the writing process of the manuscript nor the decision to submit the manuscript for publication. They will not have ultimate authority over any of these activities.

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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

Publicated to:BMC CANCER. 22 (1): 536- - 2022-12-01 22(1), DOI: 10.1186/s12885-022-09572-7

Authors: Pereira, Fernando; Serrano, Angel; Manzanedo, Israel; Perez-Viejo, Estibalitz; Gonzalez-Moreno, Santiago; Gonzalez-Bayon, Luis; Arjona-Sanchez, Alvaro; Torres, Juan; Ramos, Isabel; Barrios, Maria E.; Cascales, Pedro; Morales, Rafael; Boldo, Enrique; Garcia-Fadrique, Alfonso; Arteaga, Xabier; Gutierrez-Calvo, Alberto; Sanchez-Garcia, Susana; Asensio, Enrique; Ramirez, Cesar P.; Artiles, Manuel; Vaque, Javier; Parra, Pedro A.; Villarejo, Pedro; Munoz-Casares, Cristobal; Turienzo, Estrella; Calero, Alicia; Torrejimeno, Isabel Jaen; Prieto, Isabel; Galindo, Julio; Borrego, Vicente; Marcello, Manuel E.; Rihuete, Cristina; Carrasco, Joaquin; Gomez-Quiles, Luis;

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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/m(2) (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/m(2)) 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 effectiveness of HIPEC with high-dose mytomicin-C in preventing the development of peritoneal recurrence in patients with limited peritoneal metastasis from colon cancer (not rectal), after complete surgical cytoreduction. This study will be performed in 31 Spanish HIPEC centres, starting in March 2022. Additional international recruiting centres are under consideration. Two hundred sixteen patients with PCI <= 20, in which complete cytoreduction (CCS 0) has been obtained, will be randomized intraoperatively to arm 1 (with HIPEC) or arm 2 (without HIPEC). We will stratified randomization by surgical PCI (1-10; 11-15; 16-20). Patients in both arms will be treated with personalized systemic chemotherapy. Primary endpoint is peritoneal recurrence-free survival at 3 years. An ancillary study will evaluate the correlation between surgical and pathological PCI, comparing their respective prognostic values.Discussion: HIPEC with high-dose mytomicin-C, in patients with limited (PCI <= 20) and completely resected (CCS 0) peritoneal metastases, is assumed to reduce the expected risk of peritoneal recurrence from 50 to 30% at 3 years.

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