Clinical trial: Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study (NCT03917173)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment