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Spots Global Cancer Trial Database for Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

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Trial Identification

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

Official Title: 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

Study ID: NCT03917173

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

IRCCS Istituto Tumori Giovanni Paolo II, Bari, , Italy

AO Santa Croce e Carle, Cuneo, , Italy

ULLS1 1 Dolomiti - Ospedale di Feltre, Feltre, , Italy

Policlinico di Milano, Milano, , Italy

A.O.R.N. A.Cardarelli, Napoli, , Italy

Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy

Ospedale Evangelico Betania, Napoli, , Italy

Azienda Ospedaliera S. Camillo Forlanini, Roma, , Italy

Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy

Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore, Roma, , Italy

IRCCS Policlinico San Donato, San Donato Milanese, , Italy

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

Contact Details

Name: Andrea Di Giorgio

Affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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