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Clinical Trial
. 2022 May 12;22(1):536.
doi: 10.1186/s12885-022-09572-7.

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

Fernando Pereira  1 , Angel Serrano  2 , Israel Manzanedo  2 , Estibalitz Pérez-Viejo  2 , Santiago González-Moreno  3 , Luis González-Bayón  4 , Alvaro Arjona-Sánchez  5 , Juan Torres  6 , Isabel Ramos  7 , Maria E Barrios  8 , Pedro Cascales  9 , Rafael Morales  10 , Enrique Boldó  11 , Alfonso García-Fadrique  12 , Xabier Arteaga  13 , Alberto Gutierrez-Calvo  14 , Susana Sánchez-García  15 , Enrique Asensio  16 , Cesar P Ramírez  17 , Manuel Artiles  18 , Javier Vaqué  19 , Pedro A Parra  20 , Pedro Villarejo  21 , Cristóbal Muñoz-Casares  22 , Estrella Turienzo  23 , Alicia Calero  24 , Isabel Jaén Torrejimeno  25 , Isabel Prieto  26 , Julio Galindo  27 , Vicente Borrego  28 , Manuel E Marcello  29 , Cristina Rihuete  30 , Joaquin Carrasco  31 , Luis Gomez-Quiles  32
Affiliations
Clinical Trial

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

Fernando Pereira et al. BMC Cancer. .

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 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.

Trial registration: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).

Keywords: Colon cancer; HIPEC; Peritoneal carcinomatosis; Peritoneal metastases.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow-diagram GECOP-MMC trial. PM-CC: peritoneal metastases from colon cancer; PCI: Peritoneal Cancer Index; CCS: Completeness of cytoreduction score; MTB: multidisciplinary tumour board; HIPEC: hyperthermic intraperitoneal chemotherapy
See this image and copyright information in PMC

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