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

Recruiting

• Conditions: colorectal cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-513376-17-00
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale Dei Tumori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection), Curative (microscopically complete) surgery performed by laparotomy or laparoscopy, presence of at least one of the following risk factors for the development of metacrhonous PM: • perforated primary tumor (any T, N0-2b, M0); • primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);, age >18;, performance status 2 according to the WHO score, willingness to start adjuvant s-CT and post-operative follow-up, Signing of informed consent.

Exclusion Criteria

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

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.