Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in gastric carcinoma at high risk of peritoneal carcinomatosis. Short and long-term outcomes. A collaborative randomized controlled trial of: ACOI, FONDAZIONE AIOM, SIC, SICE, SICO. GOETH STUDY - GOETH STUDY

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with gastric carcinoma at high risk of developing peritoneal carcinomatosis, suitable to radical surgery.
Sponsor: Associazione Chirurghi Ospedalieri Italiani
Enrollment: 240
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

June 15, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0:
•a)Presurgical or intraoperative stage T3\-T4 N0\-N\+ primary tumour (TNM 8 th).
•b)Urgent presentation: perforation without purulent generalized peritonitis
•c)Positive cytology of peritoneal fluid (if previously obtained)
•2\.Age \= 18 years and \=75 years.
•3\.Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 120

•1\.Gastroesophageal Junction (GEJ) cancer
•2\.Distant metastatic disease (even if limited and completely resected)
•3\.Peritoneal carcinomatosis
•4\.History of tumour 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\).