Clinical trial · Interventional
Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard surgery | Procedure | — | UNRESOLVED |
| Surgery plus HIPEC CO2 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin
- interventionNames
- Procedure: Surgery plus HIPEC CO2
- type
- ACTIVE_COMPARATOR
- label
- Comparator
- description
- Standard surgery
- interventionNames
- Procedure: Standard surgery
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- This outcome measure will be assessed approximately 3 years after the last patient enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0. 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: 1. Gastroesophageal Junction (GEJ) cancer 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.
References
Publications (1)
- DERIVEDDi 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. PMID 36457115