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Clinical Trial on HIPEC with ...

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

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2029-10-31

Brief Summary

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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.

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Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)

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Detailed Description

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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.

Conditions

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Peritoneal Carcinomatosis Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

Group Type ACTIVE_COMPARATOR

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

Intervention Type DRUG

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 without HIPEC

Group Type EXPERIMENTAL

complete cytoreductive surgery without HIPEC

Intervention Type PROCEDURE

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

Interventions

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complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

Intervention Type DRUG

complete cytoreductive surgery without HIPEC

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

Intervention Type PROCEDURE

Eligibility Criteria

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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% of all colon adenocarcinomas).
2. Absence of previously treated or current extraperitoneal metastases, including distant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, or lung metastases (ruled out by PET-scan in case of doubt).
3. Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).
4. Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).
5. Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
6. Age\> 18 years.
7. Acceptable anesthetic/surgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). No severe alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).
8. Information to the patient and signing of a study-specific informed consent.

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 for geographical, social or psychological reasons.

Exclusion Criteria

1. Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.
2. No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (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 carcinoma in 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Fernando Pereira

Principal Investigator, Head of Surgery Dpt, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando Pereira, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Fuenlabrada, Madrid, Spain

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Spain

Central Contacts

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Fernando Pereira, PhD

Role: primary

[email protected]

+34916006455

Angel SERRANO, PhD

Role: backup

Israel MANZANEDO, PhD

Role: backup

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Pereira F, Serrano A, Manzanedo I, Perez-Viejo E, Gonzalez-Moreno S, Gonzalez-Bayon L, Arjona-Sanchez A, Torres J, Ramos I, Barrios ME, Cascales P, Morales R, Boldo E, Garcia-Fadrique A, Arteaga X, Gutierrez-Calvo A, Sanchez-Garcia S, Asensio E, Ramirez CP, Artiles M, Vaque J, Parra PA, Villarejo P, Munoz-Casares C, Turienzo E, Calero A, Torrejimeno IJ, Prieto I, Galindo J, Borrego V, Marcello ME, Rihuete C, Carrasco J, Gomez-Quiles L. 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. doi: 10.1186/s12885-022-09572-7.

Reference Type BACKGROUND

PMID: 35549912 (View on PubMed)

Other Identifiers

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2019-004679-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GECOP-MMC

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)

Detailed Description

Conditions

Study Design

Study Groups

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

complete cytoreductive surgery without HIPEC

Interventions

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Instituto de Investigación Hospital Universitario La Paz

Hospital Universitario de Fuenlabrada

Responsible Party

Fernando Pereira

Principal Investigators

Fernando Pereira, PhD

Locations

Hospital General Universitario de Elche

Hospital Universitario Torrecárdenas

Complejo Hospitalario Universitario de Badajoz

Hospital Sant Joan Despi Moises Broggi

Hospital General Universitario de Castellón

Consorcio Hospitalario Provincial de Castellón

Hospital General Universitario de Ciudad Real

Hospital Universitario Reina Sofía

Hospital Universitario Donostia

Hospital Universitario de Gran Canaria Doctor Negrín

Hospital Universitario Principe de Asturias

Hospital Universitario Fundación Alcorcón

HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)

Hospital General Universitario Gregorio Marañón

Md Anderson Cancer Center

Hospital Universitario Ramón Y Cajal

Fundación Jiménez Díaz

Hospital Universitario La Paz

Hospital Universitario Infanta Elena

Hospital Universitario Son Espases

Hospital Universitario Virgen de La Arrixaca

Hospital General Universitario Reina Sofía

Hospital Quirónsalud Málaga

Hospital Regional Universitario de Málaga

Hospital Universitario Central de Asturias

Hospital Universitario Virgen Del Rocío

Instituto Valenciano de Oncología

Hospital Clinico Universitario de Valencia

Hospital Universitario Y Politécnico La Fe

Hospital Universitario Río Hortega

Hospital Clínico Universitario "Lozano Blesa"

Countries

Central Contacts

Fernando Pereira, PhD

Facility Contacts

Alicia CALERO

Alicia CALERO

Juan TORRES MELERO

Juan TORRES MELERO

Isabel JAEN TORREJIMENO

iSABEL JAEN TORREJIMENO

Lana BIJELIC

Lana BIJELIC

Luis GOMEZ-QUILES

Luis GOMEZ-QUILES

Enrique BOLDÓ RODA

Enrique BOLDÓ RODA

Susana SÁNCHEZ GARCÍA