Actively Recruiting
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Led by Michael Bau Mortensen · Updated on 2022-10-06
60
Participants Needed
1
Research Sites
480 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in Resected High Risk Colon Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radically resected colon cancer patients with high-risk tumors defined as perforated, pT4NanyM0, or pTanyNanyM1 with radically resected peritoneal metastases including ovarian metastases
- Performance status 0-1
- Fertile women must use approved contraceptives
- Age over 18 years
- Written informed consent
You will not qualify if you...
- Radiologically or clinically proven relapse
- Previous cytoreductive surgery with HIPEC
- Other malignant diagnosis within the last 2 years
- Contraindications to laparoscopy such as severe adhesions or peritonitis
- History of allergic reaction to oxaliplatin or other platinum compounds
- Renal impairment with GFR less than 50 ml/min
- Myocardial insufficiency classified as NYHA class greater than 2
- Impaired liver function with bilirubin 1.5 times or more above normal
- Inadequate blood cell counts with ANC 1.5 x 10^9/l or lower and platelets 100 x 10^9/l or lower
- Any other condition or therapy that may risk patient safety or interfere with study goals
AI-Screening
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Trial Site Locations
Total: 1 location
1
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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