Biliary Stenting With or Without Photodynamic Therapy in Treating Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma or Other Biliary Tract Tumors That Cannot Be Removed by Surgery (Photostent-02)
RATIONALE: Biliary stenting is the placement of a tube in the bile ducts to keep a blocked area open. Photodynamic therapy uses a drug, such as porfimer sodium, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. It is not yet known whether biliary stenting is more effective with or without photodynamic therapy in treating patients with biliary tract tumors.
PURPOSE: This randomized phase III trial is studying biliary stenting to see how well it works compared with biliary stenting and photodynamic therapy using porfimer sodium in treating patients with locally advanced, recurrent, or metastatic cholangiocarcinoma or other biliary tract tumors that cannot be removed by surgery.
Extrahepatic Bile Duct Cancer
Drug: porfimer sodium
Procedure: biliary stenting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall survival [ Time Frame: minimum follow up 3 years or until death ] [ Designated as safety issue: No ]
- Progression-free survival every 3 months [ Time Frame: minimum follow up 3 years or until death ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTC v. 3.0 [ Time Frame: patients followed up for minimum of 3 years ] [ Designated as safety issue: Yes ]
- Quality of life as assessed by EORTC QLQ 30 and PAN 26 at baseline and 1, 3, and 6 months after completion of study treatment [ Time Frame: patients followed up for a minimum of 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A
Biliary Stenting alone
|Procedure: biliary stenting|
Experimental: Arm B
Photodynamic Therapy plus biliary stenting
|Drug: porfimer sodium Procedure: biliary stenting|
- 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 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|University College Hospital|
|London, England, United Kingdom, NW1 2PG|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Study Chair:||Stephen P. Pereira, MD||University College London Hospitals|