RT Journal Article
T1 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.
A1 Pereira, Fernando
A1 Serrano, Angel
A1 Manzanedo, Israel
A1 Perez-Viejo, Estibalitz
A1 Gonzalez-Moreno, Santiago
A1 Gonzalez-Bayon, Luis
A1 Arjona-Sanchez, Alvaro
A1 Torres, Juan
A1 Ramos, Isabel
A1 Barrios, Maria E
A1 Cascales, Pedro
A1 Morales, Rafael
A1 Boldo, Enrique
A1 Garcia-Fadrique, Alfonso
A1 Arteaga, Xabier
A1 Gutierrez-Calvo, Alberto
A1 Sanchez-Garcia, Susana
A1 Asensio, Enrique
A1 Ramirez, Cesar P
A1 Artiles, Manuel
A1 Vaque, Javier
A1 Parra, Pedro A
A1 Villarejo, Pedro
A1 Muñoz-Casares, Cristobal
A1 Turienzo, Estrella
A1 Calero, Alicia
A1 Jaen-Torrejimeno, Isabel
A1 Prieto, Isabel
A1 Galindo, Julio
A1 Borrego, Vicente
A1 Marcello, Manuel E
A1 Rihuete, Cristina
A1 Carrasco, Joaquin
A1 Gomez-Quiles, Luis
K1 Colon cancer
K1 HIPEC
K1 Peritoneal carcinomatosis
K1 Peritoneal metastases
AB 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. 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. 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. EudraCT number: 2019-004679-37.
PB BioMed Central
YR 2022
FD 2022-05-12
LK http://hdl.handle.net/10668/20279
UL http://hdl.handle.net/10668/20279
LA en
NO Pereira F, Serrano A, Manzanedo I, Pérez-Viejo E, González-Moreno S, González-Bayón L, et al. 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. BMC Cancer. 2022 May 12;22(1):536
DS RISalud
RD Apr 19, 2025