Phase II study of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.

Phase 1

Active, not recruiting

• Conditions: Patients with colon adenocarcinoma (proximal to peritoneal reflection) in stage pT4a / b, N0-2, M0, or with primitive perforated tumor undergoing curative surgery.; MedDRA version: 21.1Level: PTClassification code 10055114Term: Colon cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2020-000604-11-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-22
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) histopathologically confirmed intestinal-type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above the peritoneal reflection);
2) curative (microscopically complete) surgery performed by laparotomy or laparoscopy;
3) presence of at least one of the following risk factors for the development of metachronous PM:
- primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0);
- primary tumor directly invading adjacent organs (pT4b, N0-2b, M0);
- perforated primary tumor (any T, N0-2b, M0);
4) age >18;
5) performance status =2 according to the WHO score
6) willingness to start adjuvant systemic therapy and post-operative follow-up;
7) signature of 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1)active sepsis;
2)impaired cardiac function (history of previous heart failure or 40% FE);
3)impaired renal function (serum creatinine >1.5 normal value or creatinine clearance < 60 ml/min);
4) impaired liver function (AST, ALT, bilirubin > 1.5 normal value);
5)impaired bone marrow function (leukocytes <4000/mm3, neutrophils <1500/mm3, platelets <80000/mm3);
6)impaired lung function (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age);
7) presence of extra-abdominal and/or hepatic metastases at CT scan of the chest, abdomen and pelvis with an intravenous contrast medium;
8) severe complications (grade 3-4) after primary cancer surgery;
9) haemorrhagic diathesis or coagulopathy;
10) pregnancy or lactation in progress;
11) psychiatric or neurological conditions that preclude the procedures of the protocol;
12) contraindications to laparoscopy;
13) known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients;
14) history of previous malignancies treated in the last three years, excluding cutaneous spinocellular carcinoma and/or basocellular carcinoma;
15) prior pre-operative radio-chemotherapy.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective: of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.;Secondary Objective: Secondary Objectives: are to assess feasibility, toxicity and impact on the quality of life (QoV) of the adjuvant PIPAC, performed in an early setting (within 4-8 weeks of primitive surgery), overall survival, disease-free survival (peritoneal and distant), and pattern of disease progression after the procedure;Primary end point(s): The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.;Timepoint(s) of evaluation of this end point: 30 months