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.

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 iden...

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Autores: Pereira F, Serrano A, Manzanedo I, Pérez-Viejo E, González-Moreno S, González-Bayón L, Arjona-Sánchez A, Torres J, Ramos I, Barrios ME, Cascales P, Morales R, Boldó E, García-Fadrique A, Arteaga X, Gutierrez-Calvo A, Sánchez-García S, Asensio E, Ramírez CP, Artiles M, Vaqué J, Parra PA, Villarejo P, Muñoz-Casares C, Turienzo E, Calero A, Torrejimeno IJ, Prieto I, Galindo J, Borrego V, Marcello ME, Rihuete C, Carrasco J, Gomez-Quiles L
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p16577
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/16577
Access Level:acceso abierto
Palabra clave:Colon cancer
HIPEC
Peritoneal carcinomatosis
Peritoneal metastases
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spelling 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.Pereira FSerrano AManzanedo IPérez-Viejo EGonzález-Moreno SGonzález-Bayón LArjona-Sánchez ATorres JRamos IBarrios MECascales PMorales RBoldó EGarcía-Fadrique AArteaga XGutierrez-Calvo ASánchez-García SAsensio ERamírez CPArtiles MVaqué JParra PAVillarejo PMuñoz-Casares CTurienzo ECalero ATorrejimeno IJPrieto IGalindo JBorrego VMarcello MERihuete CCarrasco JGomez-Quiles LColon cancerHIPECPeritoneal carcinomatosisPeritoneal metastasesBACKGROUND: 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. TRIAL REGISTRATION: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).BMC2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/16577BMC CANCERISSN: 14712407reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p165772026-06-07T16:35:31Z
dc.title.none.fl_str_mv 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.
title 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.
spellingShingle 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.
Pereira F
Colon cancer
HIPEC
Peritoneal carcinomatosis
Peritoneal metastases
title_short 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.
title_full 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.
title_fullStr 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.
title_full_unstemmed 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.
title_sort 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.
dc.creator.none.fl_str_mv Pereira F
Serrano A
Manzanedo I
Pérez-Viejo E
González-Moreno S
González-Bayón L
Arjona-Sánchez A
Torres J
Ramos I
Barrios ME
Cascales P
Morales R
Boldó E
García-Fadrique A
Arteaga X
Gutierrez-Calvo A
Sánchez-García S
Asensio E
Ramírez CP
Artiles M
Vaqué J
Parra PA
Villarejo P
Muñoz-Casares C
Turienzo E
Calero A
Torrejimeno IJ
Prieto I
Galindo J
Borrego V
Marcello ME
Rihuete C
Carrasco J
Gomez-Quiles L
author Pereira F
author_facet Pereira F
Serrano A
Manzanedo I
Pérez-Viejo E
González-Moreno S
González-Bayón L
Arjona-Sánchez A
Torres J
Ramos I
Barrios ME
Cascales P
Morales R
Boldó E
García-Fadrique A
Arteaga X
Gutierrez-Calvo A
Sánchez-García S
Asensio E
Ramírez CP
Artiles M
Vaqué J
Parra PA
Villarejo P
Muñoz-Casares C
Turienzo E
Calero A
Torrejimeno IJ
Prieto I
Galindo J
Borrego V
Marcello ME
Rihuete C
Carrasco J
Gomez-Quiles L
author_role author
author2 Serrano A
Manzanedo I
Pérez-Viejo E
González-Moreno S
González-Bayón L
Arjona-Sánchez A
Torres J
Ramos I
Barrios ME
Cascales P
Morales R
Boldó E
García-Fadrique A
Arteaga X
Gutierrez-Calvo A
Sánchez-García S
Asensio E
Ramírez CP
Artiles M
Vaqué J
Parra PA
Villarejo P
Muñoz-Casares C
Turienzo E
Calero A
Torrejimeno IJ
Prieto I
Galindo J
Borrego V
Marcello ME
Rihuete C
Carrasco J
Gomez-Quiles L
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Colon cancer
HIPEC
Peritoneal carcinomatosis
Peritoneal metastases
topic Colon cancer
HIPEC
Peritoneal carcinomatosis
Peritoneal metastases
description 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. TRIAL REGISTRATION: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/16577
url https://incliva.portalinvestigacion.com/publicaciones/16577
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv BMC CANCER
ISSN: 14712407
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
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instname_str INCLIVA
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