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Brief Title: Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.
Official Title: Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY
Study ID: NCT03914820
Brief Summary: This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility. Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center
Detailed Description: This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility. Patient will be randomized in a 1:1 ratio. Randomization will be done during surgery if the total resection of tumour will be reached and will use a stratification procedure based on center The HIPEC CO2 regimen will be as reported below: mitomycin: (total dose of 35 mg/mq, physiologic solution 0.9%) administrated 50% at time 0 from start of HIPEC CO2 treatment (17.5 mg/mq), 25% (8.8 mg/mq) after 30 minutes and the last dose 25% after 60 minutes. Recommended temperature for HIPEC treatment is 41-42 °C for 90 minutes. Adjuvant treatment consists of a 6 months chemotherapy after surgery. It is possible to choose between Oxaliplatin, Capecitabine (XELOX) or Oxaliplatin, Fluorouracil, Leucovorin (FOLFOX-4) Patients affected by CRC at high risk of developing peritoneal carcinomatosis will be randomized in the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS Istituto Tumori Giovanni Paolo II, Bari, , Italy
ASP PO Sant'Elia, Caltanissetta, , Italy
AO Santa Croce e Carle, Cuneo, , Italy
ULLS1 1 Dolomiti - Ospedale di Feltre, Feltre, , Italy
Ospedale dell Angelo, Mestre, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Policlinico di Milano, Milano, , Italy
A.O.R.N. A. Cardarelli, Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Ospedale Evangelico Betania, Napoli, , Italy
AOU Policlinico Paolo Giaccone, Palermo, , Italy
Azienda Ospedaliera S. Camillo Forlanini, Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy
Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore, Roma, , Italy
IRCCS Policlinico San Donato, San Donato Milanese, , Italy
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Name: Fabio Pacelli, MD
Affiliation: fabio.pacelli@policlinicogemelli.it
Role: PRINCIPAL_INVESTIGATOR