RecruitingPhase 4NCT05250648

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

Sponsor

Hospital Universitario de Fuenlabrada

Enrollment

216 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Peritoneal Carcinomatosis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a heated chemotherapy wash directly into the abdominal cavity (called HIPEC) during surgery improves outcomes for patients with colon cancer that has spread to the lining of the abdomen (called peritoneal metastases). Surgeons first remove all visible cancer, then rinse the cavity with a heated drug called mitomycin C. **You may be eligible if...** - You have confirmed colon cancer (adenocarcinoma) that has spread to the peritoneum (the lining of the abdomen) - The spread is limited (a score of 20 or less on a standardized scale) - All visible cancer can be fully removed with surgery - You are also receiving systemic chemotherapy - You are 18 or older and in good enough health to tolerate major surgery **You may NOT be eligible if...** - Your cancer has spread outside the abdomen (e.g., to the liver, lungs, or lymph nodes outside the abdomen) - You have a signet ring cell carcinoma (a rare and aggressive subtype) - You have peritoneal cancer from another primary source (e.g., rectal or appendix cancer) - Your overall health is too poor for major surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcomplete cytoreductive surgery plus HIPEC with Mytomicin C for 90 minutes

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

PROCEDUREcomplete cytoreductive surgery without HIPEC

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

Locations(31)

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital Universitario Torrecárdenas

Almería, Almería, Spain

Complejo Hospitalario Universitario de Badajoz

Badajoz, Badajoz, Spain

Hospital Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, Spain

Hospital General Universitario de Castellón

Castellon, Castellón, Spain

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Ciudad Real, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

HOSPITAL UNIVERSITARIO DE FUENLABRADA (Coordinating Centre)

Fuenlabrada, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Md Anderson Cancer Center

Madrid, Madrid, Spain

Hospital Universitario Ramón Y Cajal

Madrid, Madrid, Spain

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, Spain

Hospital General Universitario Reina Sofía

Murcia, Murcia, Spain

Hospital Quirónsalud Málaga

Málaga, Málaga, Spain

Hospital Regional Universitario de Málaga

Málaga, MÁLAGA, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Virgen Del Rocío

Seville, Sevilla, Spain

Instituto Valenciano de Oncología

Valencia, Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT05250648

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