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

Last updated: October 6, 2024
Sponsor: Hospital Universitario de Fuenlabrada
Overall Status: Active - Recruiting

Phase

4

Condition

Colon Cancer

Carcinoma

Abdominal Cancer

Treatment

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

Clinical Study ID

NCT05250648
GECOP-MMC
2019-004679-37
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with > 50% of the tumor composed of these cells, which comprise only 1% ofall colon adenocarcinomas).

  2. Absence of previously treated or current extraperitoneal metastases, includingdistant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, orlung metastases (ruled out by PET-scan in case of doubt).

  3. Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with aPCI ≤ 20 (Appendix 2) (intraoperative confirmation).

  4. Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).

  5. Treatment with perioperative systemic chemotherapy (SCT), before and/or aftersurgical procedure.

  6. Age> 18 years.

  7. Acceptable anesthetic/surgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). Nosevere alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).

  8. Information to the patient and signing of a study-specific informed consent.

Exclusion

Exclusion Criteria:

  1. Peritoneal carcinomatosis of any other origin, particularly rectal cancer orappendicular adenocarcinoma, or signet ring cell colon cancer on histology.

  2. No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases ofperianastomotic (local) or lymph node (locoregional) recurrences will be excluded.

  3. High volume peritoneal disease with a PCI> 20 (intraoperative evaluation).

  4. Concurrent or previously treated extraperitoneal disease.

  5. Disease progression during preoperative chemotherapy, if received.

  6. Patients previously treated with HIPEC.

  7. History of other cancers (except cutaneous basal cell carcinoma or cervix carcinomain situ) in the 5 years prior to entry into the study.

  8. Patients included in another first-line clinical trial for the studied disease.

  9. Pregnancy (or suspicion of it) or lactation period.

  10. Emergency surgical intervention for obstruction or perforation of a primary tumourwith synchronous PM (although rescue and secondary CRS + HIPEC after emergencysurgery of the primary tumour are acceptable if inclusion criteria are fulfilled).

  11. Persons deprived of liberty or under legal or administrative supervision.

  12. Inability to understand the nature of the intervention, the risks, benefits,expected evolution and the need to undergo periodic medical examinations, either forgeographical, social or psychological reasons.

Study Design

Total Participants: 216
Treatment Group(s): 2
Primary Treatment: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes
Phase: 4
Study Start date:
March 02, 2022
Estimated Completion Date:
October 31, 2029

Study Description

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.

Connect with a study center

  • Hospital General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Sant Joan Despi Moises Broggi

    Sant Joan Despí, Barcelona 08970
    Spain

    Active - Recruiting

  • Hospital General Universitario de Castellón

    Castelló de la Plana, Castellón 12004
    Spain

    Active - Recruiting

  • Consorcio Hospitalario Provincial de Castellón

    Castellón De La Plana, Castellón 12006
    Spain

    Active - Recruiting

  • Hospital Universitario Donostia

    San Sebastián, Gipuzkoa 20014
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas De Gran Canaria, Gran Canaria 35010
    Spain

    Active - Recruiting

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid 28805
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Active - Recruiting

  • HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)

    Fuenlabrada, Madrid 28942
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Elena

    Valdemoro, Madrid 28340
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma De Mallorca, Mallorca 07210
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Universitario Torrecárdenas

    Almería, 04009
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Badajoz

    Badajoz, 6080
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Md Anderson Cancer Center

    Madrid, 28033
    Spain

    Site Not Available

  • Hospital General Universitario Reina Sofía

    Murcia, 30003
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Málaga

    Málaga, 29004
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncología

    Valencia, 46009
    Spain

    Active - Recruiting

  • Hospital Universitario Río Hortega

    Valladolid, 47012
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza, 50009
    Spain

    Active - Recruiting

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