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

NCT05250648 | Recruiting Phase 4 DMC

• 2 other identifiers: GECOP-MMC2019-004679-37
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

Peritoneal Carcinomatosis; Colon Cancer

Keywords

HIPEC; Mitomycin; Colon Neoplasms; Peritoneal metastasis

Outcome Measures

Primary Outcomes (1)

• Peritoneal Recurrence Free Survival

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

  3 years

Secondary Outcomes (7)

• Global recurrence at any location (Disease Free Survival)

  3 years

• Locoregional and distant recurrence rate (isolated or coincident, with or without simultaneous peritoneal recurrence)

  3 years

• Postoperative complications (rate and severity grade)

  days 1-90 after surgery

• Peritoneal and global recurrence rate according to stratified PCI

  3 years

• Overall survival

  3 years

Study Arms (2)

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

ACTIVE COMPARATOR

Drug: complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC

EXPERIMENTAL

Procedure: complete cytoreductive surgery without HIPEC

Interventions

complete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes 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 plus HIPEC with Mytomicin C for 90 minutes

complete cytoreductive surgery without HIPEC PROCEDURE

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

complete cytoreductive surgery without HIPEC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).
• Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).
• Treatment with perioperative systemic chemotherapy (SCT), before and/or after surgical procedure.
• Age\> 18 years.
• 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).
• Information to the patient and signing of a study-specific informed consent.

You may not qualify if:

• Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.
• No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.
• High volume peritoneal disease with a PCI\> 20 (intraoperative evaluation).
• Concurrent or previously treated extraperitoneal disease.
• Disease progression during preoperative chemotherapy, if received.
• Patients previously treated with HIPEC.
• History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.
• Patients included in another first-line clinical trial for the studied disease.
• Pregnancy (or suspicion of it) or lactation period.
• Persons deprived of liberty or under legal or administrative supervision.
• 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.

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada: lead
• Instituto de Investigación Hospital Universitario La Paz: collaborator

Study Sites (31)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Hospital Universitario Torrecárdenas

Almería, Almería, 04009, Spain

RECRUITING

Complejo Hospitalario Universitario de Badajoz

Badajoz, Badajoz, 6080, Spain

RECRUITING

Hospital Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital General Universitario de Castellón

Castellon, Castellón, 12004, Spain

RECRUITING

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, 12006, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, 13005, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, 20014, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Gran Canaria, 35010, Spain

RECRUITING

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Md Anderson Cancer Center

Madrid, Madrid, 28033, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Ramón Y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Infanta Elena

Valdemoro, Madrid, 28340, Spain

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, 07210, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital General Universitario Reina Sofía

Murcia, Murcia, 30003, Spain

RECRUITING

Hospital Quirónsalud Málaga

Málaga, Málaga, 29004, Spain

ACTIVE NOT RECRUITING

Hospital Regional Universitario de Málaga

Málaga, MÁLAGA, 29010, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario Virgen Del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitario Y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 35549912 BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms; Colonic Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Fernando Pereira, PhD

  Hospital Universitario de Fuenlabrada, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Pereira, PhD

CONTACT

+34916006455; fernando.pereira@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Surgery Dpt, Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 22, 2022
• Study Start: March 2, 2022
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available beginning 9 months and ending 36 months following article publication
• Access Criteria: To obtain the data, a proposal must be sent to fernando.pereira@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ES (31)