An interventional study of Surgery plus HIPEC CO2 and Standard surgery in Stomach Neoplasms, sponsored by Mario Negri Institute for Pharmacological Research. Recruiting at 13 sites in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Mario Negri Institute for Pharmacological Research · Not applicable, Interventional, and Treatment
This is a phase III randomized, multicenter study with two different arm:
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:
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 240 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.
Exclusion Criteria:
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
Procedure: Surgery plus HIPEC CO2
Standard surgery
Procedure: Standard surgery
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Standard surgery without HIPEC CO2
Disease 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
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
Plan to share: No
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Mario Negri Institute for Pharmacological Research