Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study
NCT ID: NCT03917173
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2020-06-01
2025-06-01
Brief Summary
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* 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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
* experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
* comparator: standard surgery
TREATMENT
NONE
Study Groups
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Experimental
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
Surgery plus HIPEC CO2
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Comparator
Standard surgery
Standard surgery
Standard surgery without HIPEC CO2
Interventions
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Surgery plus HIPEC CO2
Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
Standard surgery
Standard surgery without HIPEC CO2
Eligibility Criteria
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Inclusion Criteria
1. Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
2. Urgent presentation: perforation without purulent generalized peritonitis
3. Positive cytology of peritoneal fluid (if previously obtained)
2. Age ≥ 18 years and ≤75 years.
3. Written informed consent.
Exclusion Criteria
2. Distant metastatic disease (even if limited and completely resected)
3. Peritoneal carcinomatosis
4. History of tumor diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
5. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
6. Poor general conditions (ECOG \> 2).
7. Impaired cardiac function (history of congestive heart failure or FE \<40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class \> II) or serious uncontrolled cardiac Arrhythmia requiring medication
8. Impaired renal function (creatinine\> 1.5 upper limit of normal or creatinine clearance \<60 mL / min).
9. Impaired hepatic function (AST, ALT \>2.5 upper limit of normal, bilirubin \> 1.5 upper limit of normal).
10. Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm 3, platelets \<100000 / mm3).
11. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value).
12. History or presence of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
13. Pregnancy.
14. Krukenberg tumor
15. Refusal to join the study.
18 Years
75 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Andrea Di Giorgio
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
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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
Milan, , 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
Countries
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Central Contacts
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Facility Contacts
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Alberto Biondi
Role: primary
Andrea Di Giorgio, MD
Role: primary
References
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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.
Other Identifiers
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2019-001478-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IRFMN-GCC-7813
Identifier Type: -
Identifier Source: org_study_id
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