Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, patients will be offered two Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) treatments with oxaliplatin after primary resection and standard adjuvant chemotherapy (if indicated) for colon cancer. Furthermore, the study will explore, whether it is possible to find free intraperitoneal tumor cells (FITC) after resection and adjuvant chemotherapy for colon cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Bau Mortensen
• Treatments: Oxaliplatin

Criteria

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)

• Age > 18 years

• Written informed consent

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.