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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
Standard surgery without HIPEC CO2
Prophylactic surgery plus HIPEC CO2 performed with mitomycin
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
RECRUITINGASP PO Sant'Elia
Caltanissetta, Italy
Local recurrence free survival (LRFS)
The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.
Time frame: This outcome measure will be assess approximately 3 years after the last patient enrolled
Disease Free Survival (DFS)
Disease Free Survival (DFS) DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first. OS is defined as the time from randomization to death for any cause.
Time frame: This outcome measure will be assess approximately 3 years after the last patient enrolled
Overall Survival (OS)
death for any cause
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
number of post-surgery complication
any type of complication
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
morbidity
evaluated during and after surgery, graded according to the NCI-CTAE version 4.03 for AE related to chemotherapy and according to Clavien Dindo for surgery complications
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
duration of surgery
timing of surgery
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
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AO Santa Croce e Carle
Cuneo, Italy
ACTIVE_NOT_RECRUITINGULLS1 1 Dolomiti - Ospedale di Feltre
Feltre, Italy
ACTIVE_NOT_RECRUITINGOspedale dell Angelo
Mestre, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
RECRUITINGPoliclinico di Milano
Milan, Italy
RECRUITINGA.O.R.N. A. Cardarelli
Naples, Italy
RECRUITINGAzienda Ospedaliera Universitaria Federico II
Naples, Italy
RECRUITINGOspedale Evangelico Betania
Naples, Italy
ACTIVE_NOT_RECRUITING...and 6 more locations
number of patients performing the adjuvant chemotherapy.
patients performing the adjuvant chemotherapy
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
length of hospitalization
length of hospitalization
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
mortality at 30 and 90 days from surgery
mortality at 30 and 90 days from surgery
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled