Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in
preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
- Determine any improvement in the quality of life of patients treated with this
OUTLINE: This is a nonrandomized study.
Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal
adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the
abdominal cavity by hyperthermic perfusion over 60 minutes.
Quality of life is assessed at study entry and at 4 weeks.
After completion of study treatment, patients are followed periodically for 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prevention of malignant recurrence
Week 4 after treatment
Todd M. Tuttle, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|