This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin * comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms. Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.
This is a phase III randomized, multicenter study with two different arm: * experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin * 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 performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables. The primary objective of the study is to compare the efficacy of prophylactic surgery (radical gastric resection, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of disease free survival (DFS). Patients affected by gastric carcinoma at high risk of developing peritoneal carcinomatosis will be randomized in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Standard surgery without HIPEC CO2
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
ACTIVE_NOT_RECRUITINGAO Santa Croce e Carle
Cuneo, Italy
ACTIVE_NOT_RECRUITINGDisease free survival
The primary efficacy endpoint is DFS defined as the time from randomization to the date of first local relapse or distant relapse or peritoneal carcinomatosis or death for any cause, whichever comes first.
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
Overall Survival
Overall Survival (OS) defined as the time from randomization to the death for any cause
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint
Local recurrence free survival
Local recurrence free survival (LRFS) defined as the time from randomization 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 assessed approximately 3 years after the last patient enrolled, at the same time points of the Primary Endpoint
morbidity evaluated during and after surgery
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
post-surgery complication
number of post-surgery complication
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
duration of surgery
timing of surgery
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ULLS1 1 Dolomiti - Ospedale di Feltre
Feltre, Italy
ACTIVE_NOT_RECRUITINGPoliclinico di Milano
Milan, Italy
ACTIVE_NOT_RECRUITINGA.O.R.N. A.Cardarelli
Napoli, Italy
ACTIVE_NOT_RECRUITINGAzienda Ospedaliera Universitaria Federico II
Napoli, Italy
ACTIVE_NOT_RECRUITINGOspedale Evangelico Betania
Napoli, Italy
ACTIVE_NOT_RECRUITINGAzienda Ospedaliera S. Camillo Forlanini
Roma, Italy
ACTIVE_NOT_RECRUITINGFondazione Policlinico Universitario A. Gemelli
Roma, Italy
ACTIVE_NOT_RECRUITINGFondazione Policlinico Universitario A. Gemelli
Roma, Italy
RECRUITING...and 3 more locations
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled
length of hospitalization
duration 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 at 30 and 90 days from surgery
patients performing the adjuvant chemotherapy.
number of patients performing the adjuvant chemotherapy.
Time frame: This outcome measure will be assessed approximately 3 years after the last patient enrolled