NCT03917173

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Gastric Carcinoma at High Risk of Developing Peritoneal Carcinomatosis. Short and Long-term Outcomes Evaluation.A Collaborative Randomized Controlled Trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Surgery plus HIPEC CO2	Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
PROCEDURE	Standard surgery	Standard surgery without HIPEC CO2

Timeline

• Start date: 2020-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2019-04-16
• Last updated: 2023-10-26

Locations

13 sites across 1 country: Italy