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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001478-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin |
|
| Comparator | Active Comparator | Standard surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery plus HIPEC CO2 | Procedure | Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This outcome measure will be assessed approximately 3 years after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival (OS) defined as the time from randomization to the death for any cause | 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 |
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Inclusion Criteria:
Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.
Age ≥ 18 years and ≤75 years.
Written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Di Giorgio, MD | Contact | 003906 3015 | 7255 | andrea.digiorgio@policlinicogemelli.it |
| Erica Rulli | Contact | 0039023901 | 4684 | erica.rulli@marionegri.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Di Giorgio | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Tumori Giovanni Paolo II | Active, not recruiting | Bari | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36457115 | Derived | Di Giorgio A, Gerardi C, Abatini C, Melotti G, Bonavina L, Torri V, Santullo F, Garattini S, De Luca M, Rulli E, Rulli E, Pacelli F; GOETH Investigators. Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (GOETH STUDY)-a collaborative randomized controlled trial by ACOI, FONDAZIONE AIOM, SIC, SICE, and SICO. Trials. 2022 Dec 1;23(1):969. doi: 10.1186/s13063-022-06880-y. |
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This is a phase III randomized, multicenter study with two different arm:
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| Standard surgery | Procedure | Standard surgery without HIPEC CO2 |
|
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. |
| 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 | This outcome measure will be assessed approximately 3 years after the last patient enrolled |
| post-surgery complication | number of post-surgery complication | This outcome measure will be assessed approximately 3 years after the last patient enrolled |
| duration of surgery | timing of surgery | This outcome measure will be assessed approximately 3 years after the last patient enrolled |
| length of hospitalization | duration of hospitalization | 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 | 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. | This outcome measure will be assessed approximately 3 years after the last patient enrolled |
| AO Santa Croce e Carle |
| Active, not recruiting |
| Cuneo |
| Italy |
| ULLS1 1 Dolomiti - Ospedale di Feltre | Active, not recruiting | Feltre | Italy |
| Policlinico di Milano | Active, not recruiting | Milan | Italy |
| A.O.R.N. A.Cardarelli | Active, not recruiting | Naples | Italy |
| Azienda Ospedaliera Universitaria Federico II | Active, not recruiting | Naples | Italy |
| Ospedale Evangelico Betania | Active, not recruiting | Naples | Italy |
| Azienda Ospedaliera S. Camillo Forlanini | Active, not recruiting | Roma | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Active, not recruiting | Roma | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Recruiting | Roma | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Universita' Cattolica Del Sacro Cuore | Recruiting | Roma | Italy |
|
| IRCCS Policlinico San Donato | Active, not recruiting | San Donato Milanese | Italy |
| IRCCS Casa Sollievo della Sofferenza | Active, not recruiting | San Giovanni Rotondo | Italy |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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