Phase III Randomized Study of Double Plastic Endoprosthesis Insertion With Versus Without Adjuvant Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Patients With Unresectable Stage III-IV Cholangiocarcinoma
- Compare the overall survival time in patients with unresectable Bismuth type III or IV,
stage III-IV cholangiocarcinoma treated with double plastic endoprostheses insertion
with vs without adjuvant photodynamic therapy using porfimer sodium as palliative
- Compare the effect of these regimens on cholestasis in these patients.
- Compare the 1-year survival rate in patients treated with these regimens.
- Compare health-related quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are
stratified according to participating center.
Patients undergo endoscopic or percutaneous drainage followed by insertion of bilateral
plastic endoprostheses into the bile ducts. Patients are then randomized to 1 of 2 treatment
- Arm I: Patients receive porfimer sodium IV on day 1. Patients undergo endoscopic laser
light therapy to the tumor site on day 3.
- Arm II: Patients receive no further treatment. Quality of life is assessed at baseline
and then at weeks 2, 13, 26, 39, 52, and 65.
After completion of study treatment, patients are followed within 30-90 days.
PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
Primary Purpose: Treatment
James Farrell, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|