Status:
RECRUITING
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Lead Sponsor:
Michael Bau Mortensen
Conditions:
Peritoneum Cancer
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 indicate...
Detailed Description
In 2015, 3500 patients were diagnosed with colon cancer in Denmark (DCCG Årsrapport 2015, www.dccg.dk). Despite curative intended surgery and perioperative chemotherapy in colon cancers, relapse is of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03280511
Start Date
December 14 2017
End Date
March 1 2027
Last Update
October 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark, 5000