Can Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) reduce the risk of recurrence after colon resection for colon cancer?

Phase 1

Active, not recruiting

• Conditions: Recurrence after resection for colon cancer; MedDRA version: 20.0Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002637-37-DK
• Lead Sponsor: Kirurgisk Afdeling A, Odense Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-24
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Radically resected colon cancer patients with adeno- or signet ring cell carcinomas with
high-risk tumors defined as: perforated / pT4NanyM0 (UICC 8th edition) / pTanyNanyM1
with radically resected PM including ovarian metastases
• Performance status 0-1
• Fertile women must use approved contraceptives (see below)
Version 1, 18.06.2017 7
• Age > 18 years
• 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Radiologically or clinically proven relapse.
• Previous cytoreductive surgery (CRS) with HIPEC
• Other malignant diagnosis within the last 2 years
• Contraindications to laparoscopy (e.g. severe adhesions, peritonitis)
• A history of allergic reaction to oxaliplatin or other platinum containing compounds
• Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault Equation).
• Myocardial insufficiency, defined as NYHA class > 2.
• Impaired liver function defined as bilirubin = 1.5 x UNL (upper normal limit).
• Inadequate haematological function defined as ANC = 1.5 x 109/l and platelets = 100 x
109/l.
• Any other condition or therapy, which in the investigator’s opinion may pose a risk to the
patient or interfere with the study objectives.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The proportion of patients with peritoneal recurrence on contrast enhanced CT of the thorax and abdomen 36 months after resection of high-risk colon cancer.;Secondary Objective: • The number of conversions from positive to negative peritoneal lavage cytology after one<br>PIPAC procedure.<br>• Completion rate of two adjuvant PIPAC treatments<br>• Treatment related toxicity and complication rate<br>• 1- and 2-year peritoneal recurrence free survival, based on CT of the thorax and abdomen.<br>• 1-, 2- and 3-year recurrence free survival, based on CT of the thorax and abdomen<br>• 1-, 3- and 5-year overall survival rate;Primary end point(s): An estimated 25 % of patients with a pT4 or perforated primary colon tumor are expected to develop PM. Based on the preliminary results of PIPAC we expect an absolute risk reduction of 15% in an adjuvant setting.;Timepoint(s) of evaluation of this end point: 36 months from colon resection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Peritoneal recurrence free survival<br>2. Overall survival;Timepoint(s) of evaluation of this end point: 1. 12 and 24 months<br>2. 60 months