Home › Trials › NCT03917173

Prophylactic surgery with HIPEC CO2 for gastric cancer patients

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

Not applicable Interventional Mario Negri Institute for Pharmacological Research · NCT03917173

This study is testing if a new type of surgery combined with special chemotherapy can help people with high-risk gastric cancer live longer without their cancer coming back compared to standard surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorMario Negri Institute for Pharmacological Research Academic / other
Drugs / interventionschemotherapy
Locations13 sites (Bari and 12 other locations)
Trial IDNCT03917173 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of prophylactic surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) using CO2 in patients diagnosed with gastric carcinoma at high risk for peritoneal carcinomatosis. Participants will be randomly assigned to receive either the experimental treatment or standard surgery, with the primary goal of comparing disease-free survival rates between the two groups. The study involves a multicenter approach and requires patients to have histologically confirmed gastric cancer eligible for radical resection. Adjuvant treatment post-surgery is mandatory unless specific exclusions apply.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically documented gastric carcinoma eligible for radical surgery.

Not a fit: Patients with gastroesophageal junction cancer, distant metastatic disease, or peritoneal carcinomatosis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve disease-free survival rates for patients with gastric cancer.

How similar studies have performed: Previous studies have shown promise with HIPEC in various cancers, suggesting potential for success in this novel application for gastric cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bari and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stomach Neoplasmsgastric cancerHIPEC CO2Prophylactic surgeryhyperthermic intraperitoneal chemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.