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

2019-04-17 12:55:22 | BioPortfolio

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.

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.

Study Design

Conditions

Stomach Neoplasms

Intervention

Surgery plus HIPEC CO2, Standard surgery

Status

Not yet recruiting

Source

Mario Negri Institute for Pharmacological Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-04-17T12:55:22-0400

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