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Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)
Sponsor: Hospital Universitario de Fuenlabrada
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2022-03-02
Completion Date
2029-10
Last Updated
2024-10-09
Healthy Volunteers
No
Conditions
Interventions
complete 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
complete 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