Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy versus standard surgery in colorectal carcinoma at high risk of peritoneal carcinomatosis

Phase 1

• Conditions: patients with colorectal carcinoma at high risk peritoneal carcinomatosis; MedDRA version: 21.1Level: PTClassification code 10061045Term: Colon neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001437-14-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: 2021-05-24
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 165
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

Exclusion Criteria

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
11.History or presence of other diseases, 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.
12.Chronic inflammatory bowel disease
13.Patients with acute bowel obstruction
14.Refusal to join the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the efficacy of prophylactic surgery (radical colorectal resection, omentectomy, appendectomy, round ligament of the liver resection and bilateral adnexectomy) plus HIPEC CO2 versus standard surgery in terms of local recurrence free survival (LRFS) in patients with colorectal carcinoma (CRC) at high risk of developing peritoneal carcinomatosis.;Secondary Objective: The secondary objective is to compare the safety profile of prophylactic surgery plus HIPEC CO2 vs. standard surgery;Primary end point(s): The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.;Timepoint(s) of evaluation of this end point: 6 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints are: Disease Free Survival (DFS) and Overall Survival (OS). <br>DFS is defined as the time from randomization to the date of first local relapse, distant relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.<br>OS is defined as the time from randomization to death for any cause.;Timepoint(s) of evaluation of this end point: 6 years