Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Conditions
Keywords
unresectable gallbladder cancer, recurrent gallbladder cancer, metastatic gallbladder cancer, cholangiocarcinoma of the gallbladder, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, metastatic extrahepatic bile duct cancer, cholangiocarcinoma of the extrahepatic bile duct
Brief summary
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.
Detailed description
OBJECTIVES: Primary * 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. Secondary * 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.
Interventions
DRUGporfimer sodium
PROCEDUREbiliary stenting
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histopathological/cytological diagnosis of nonresectable locally advanced, recurrent, or metastatic biliary tract carcinoma (intra- or extra-hepatic), or gallbladder carcinoma * Adequate biliary drainage, with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
Exclusion criteria
* Porphyria * No brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0, 1, 2, or 3 * Estimated life expectancy \> 3 months * Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 1 month after completion of treatment * Not pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | minimum follow up 3 years or until death |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival every 3 months | minimum follow up 3 years or until death |
| Toxicity as assessed by NCI CTC v. 3.0 | patients followed up for minimum of 3 years |
| 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 | patients followed up for a minimum of 3 years |
Countries
United Kingdom
Outcome results
None listed