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In the arm with HIPEC, this will be performed with Mytomicin C, at a dose of 35 mg/m2 in peritoneal dialysis solution (2 liter/m2) for 90 minutes, with dose fractionation: 50% min 0, 25% min 30, 25% min 60

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

in the arm without HIPEC, only complete cytoreductive surgery will be performed

complete cytoreductive surgery without HIPEC

Fernando Pereira, PhD

Alicia CALERO

Estrella TURIENZO

Isabel RAMOS BERNARDO

Luis GOMEZ-QUILES

Enrique BOLDÓ RODA

Xabier ARTEAGA MARTÍN

Manuel ARTILES

Alberto GUTIERREZ CALVO

Manuel Emilio MARCELLO FERNANDEZ

Fernando PEREIRA, PhD

Angel SERRANO, PhD

Israel MANZANEDO, PhD

Estibalitz PÉREZ-VIEJO, PhD

Cristina RIHUETE CARO

Rafael MORALES SORIANO

Pedro CASCALES CAMPOS

Juan TORRES MELERO

Aránzazu PRADA VILLAVERDE

Susana SÁNCHEZ GARCÍA

Alvaro ARJONA

Luis GONZÁLEZ BAYÓN

Santiago GONZALEZ MORENO

Julio GALINDO ÁLVAREZ

Pedro VILLAREJO

Maria Isabel PRIETO NIETO

Pedro Antonio PARRA BAÑOS

Cesar P RAMÍREZ PLAZA

Cristóbal MUÑOZ CASARES

Alfonso GARCÍA FADRIQUE

Maria Eugenia BARRIOS CARVAJAL

Javier VAQUÉ URBANEJA

Enrique ASENSIO

Vicente BORREGO ESTELLA

The aim of this study is to assess whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.

CytoReductive Surgery (CRS) + Hyperthermic IntraPEritoneal Chemotherapy (HIPEC), especially from the year 2000 onwards, has obtained unprecedented results in patients with low to moderate volume peritoneal metastases (PM) of colorectal cancer (CRC), so that it has gradually been accepted, even being considered the best treatment for these patients. However, the actual role of HIPEC as a necessary component of treatment is unknown, despite its proven experimental basis. The French PRODIGE 7 study, presented at ASCO in 2018 and published on January 2021, has raised doubts about the survival benefit of HIPEC. In this study, there was no difference in overall survival (OS) with or without HIPEC (with Oxaliplatin 30 minutes) after resection of PM-CRC. However, since its presentation, several methodological flaws have been identified: a short exposure time to Oxaliplatin, an overestimation of the effect of HIPEC on OS (18 months) considered for the sample calculation, or the choice of OS as the main endpoint (since HIPEC can reduce peritoneal relapses, while OS is also influenced by the systemic treatment received by all patients). Due to these shortcomings and some others, the results have not been assumed to be definitive. Therefore, the majority of units specialized in peritoneal surface malignancy, continue to consider HIPEC in these patients as a recommended option, usually changing Oxaliplatin for Mitomycin-C (MMC). With these premises we propose this multicenter Clinical Trial, correcting the retrospective defects of PRODIGE 7. To do this, the cytostatic used in HIPEC will be changed (MMC instead of oxaliplatin), the infusion time will be increased (from 30 to 90 minutes), rectal cancers are ruled out (only colon cancers will be included), cases with high peritoneal extension (PCI\> 20) will be avoided, those cases in which a complete CRS (CCS 0) is not achieved will be excluded, and the main objective will be the Peritoneal Recurrence Free Survival (RFS) instead of the OS.

Recruitment will be carried out at the outpatient clinic, once the indication of CRS ± HIPEC (CC-PM of apparently limited volume without metastasis at other sites) has been established after presenting the case in the Multidisciplinary Tumour Board. Eligible patients need to meet the presurgical inclusion criteria (even though some criteria have to be confirmed during surgery for randomization), and sign the informed consent.

Randomization occurs intraoperatively, once the extension of peritoneal disease is found to be truly limited (PCI ≤ 20) after complete surgical exploration, and only after radical surgery (CCS 0) has been possible. At this time, patients are randomized to receive HIPEC with MMC for 90 minutes (Arm 1), or no HIPEC and therefore surgery is finished (Arm 2).

Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)

Phase IV Multicentric 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

all IPD that underlie results in a publication, after deidentification (text, tables, figures and appendices) With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? for individual participant data meta-analysis.

From the date of surgery to the date of peritoneal recurrence or death, or to the end of follow-up

From the date of surgery to the date of recurrence at any site or death

From the date of surgery to the date of locoregional and/or distant recurrence

Using the CTCAE v5.0 adverse event classification system, including those related to HIPEC.

Rate of peritoneal and global recurrence in 3 subgroups of PCI ((1-10, 11-15, 16-20)

Months from from the day of treatment initiation (either neoadjuvant SCT or upfront CRS) to the date of death or to the end of follow-up.

The QLQ-CR29 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. In fact, their numbering is consecutive (the last item of QLQ-C30 is number 30, being the first item of QLQ-CR29 number 31). Both have function and symptom scales/single-items. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.

Instituto de Investigación Hospital Universitario La Paz

Hospital Universitario de Fuenlabrada

Principal Investigator, Head of Surgery Dpt, Clinical Professor

Spots Global Cancer Trial Database for complete cytoreductive surgery plus hipec with mytomicin c for 90 minutes