Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients - The PIPAC-OPC3 CC Trial
Michael Bau Mortensen
60 participants
Dec 14, 2017
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
Interventions
PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 46 mg/m2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml/s with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03280511