Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery in gastric carcinoma at high risk of peritoneal carcinomatosis.

Phase 1

• Conditions: Patients with gastric carcinoma at high risk of developing peritoneal carcinomatosis, suitable to radical surgery.; MedDRA version: 21.0Level: LLTClassification code 10007350Term: Carcinoma gastricSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001478-27-IT
• Lead Sponsor: Associazione Chirurghi Ospedalieri Italiani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

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).
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified