Porfimer Sodium Photodynamic Therapy Plus Stenting Versus Stenting Alone in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumours: a Multicentre, Randomised, Phase Lll Study
- To assess the efficacy, in terms of overall survival, of biliary stenting with vs
without photodynamic therapy using porfimer sodium in advanced, recurrent, or
metastatic biliary tract carcinoma.
- To evaluate the two treatments arms with respect to progression-free survival, toxicity
using NCI Common Toxicity Criteria (version 3.0), and quality of life.
OUTLINE: This is a multicenter study. Patients are stratified by participating center,
primary site (gallbladder vs bile duct), disease stage (locally advanced vs metastatic),
prior therapy (i.e., surgery, radiotherapy or chemotherapy) (yes vs no), performance score
(0 vs 1 vs 2 vs 3), and prior treatment arm on UK chemotherapy trial ABC-02 (gemcitabine
hydrochloride alone vs gemcitabine hydrochloride and cisplatin). Patients are randomized to
1 of 2 arms.
- Arm I: Patients undergo either endoscopic or percutaneous drainage and insertion of
unilateral or bilateral plastic endoprostheses above the main strictures of the right
and left hepatic bile ducts.
- Arm II: Patients undergo treatment as in arm I. Patients also receive porfimer sodium
IV and then undergo laser activation 48 hours later.
After completion of study treatment, patients are followed every 3 months for at least 3
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
minimum follow up 3 years or until death
Stephen P. Pereira, MD
University College London Hospitals
United Kingdom : Medicines and Healthcare Research Authority (MHRA)