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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: patients with colorectal carcinoma at high risk peritoneal carcinomatosis
Sponsor: Associazione Chirurghi Ospedalieri Italiani
Enrollment: 330
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

May 24, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients with colon or rectosigmoid junction cancer eligible for R0 with:
•1\.Histologically documented colorectal adenocarcinoma:
•a. Presurgical or intraoperative stage T4a or T4b Primary tumour (TNM 8 th)
•b. Urgent presentation: perforation without purulent generalized peritonitis or fecal peritonitis
•c. Peritumoral minimal peritoneal carcinomatosis: limited peritoneal disease in close proximity to the primary tumour, that may be removed en bloc
•d. Ovarian metastases (Krukenberg tumor)
•2\.Age \=18 and \=75 years
•3\.Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Distant metastatic disease (even if limited and completely resected)
•2\.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).
•3\.Psychological, family or social conditions which may negatively affect the treatment and follow\-up protocol.
•4\.Poor general conditions (ECOG \> 2\).
•5\.Impaired cardiac function (history of congestive heart failure or FE \<40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrolment), myocardial infarction (\<6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class \> II or serious uncontrolled cardiac arythmia requiring medication
•6\.Impaired renal function (creatinine\> 1\.5 upper limit of normal or creatinine clearance \<60 mL / min)
•7\.Impaired hepatic function (AST, ALT \>2\.5 upper limit of normal, bilirubin\> 1\.5 upper limit of normal)
•8\.Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm3, platelets \<100000 / mm3\)
•9\.Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value).
•10\.Pregnancy