The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Andrea Di Giorgio
Affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Role: PRINCIPAL_INVESTIGATOR