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Multicentre, Randomized 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
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.
The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma. The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer. This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital de Sant Joan Despí. Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Universitario de Gran Canaria "Dr. Negrín"
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Provincial de Castellón
Castellon, Castellón, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Torrecárdenas
Almería, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Start Date
November 16, 2015
Primary Completion Date
March 1, 2024
Completion Date
March 1, 2024
Last Updated
September 28, 2023
200
ESTIMATED participants
MITOMYCIN-C 30 mg
DRUG
Proactive cytoreductive surgery
PROCEDURE
Lead Sponsor
Maimónides Biomedical Research Institute of Córdoba
NCT06696768
NCT04704661
Data Source & Attribution
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