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 - PHOTOSTENT-02
- Conditions
- Advanced or metastatic cholangiocarcinomas and other biliary tract tumours
- Registration Number
- EUCTR2005-001173-96-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
Histological/cytological confirmation of disease, not suitable for surgery, adequate biliary drainage, ECOG performance status 0, 1, 2 or 3 , life expectancy > 3 months, patient consent, age > or = 18 years
(In addition patients whose histology/cytology which is highly suspicious for malignancy in conjunction with a clinical diagnosis of biliary tract cancer (inclusing evidence of a mass lesion), may be included in the study at the TMG's decision.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Concurrent treatment for metastatic disease, other/prior malignancy or intercurrent disease, prophyria, unfit for endoscopy, pregnancy/lactation, unable to give consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether profimer sodium photodynamic therapy (PDT), in addition to standard treatment, confers an overall survival benefit in patients with advanced, non-resectable biliary tract carcinoma;Secondary Objective: To determine progression-free survival, toxicity and quality of life;Primary end point(s): Overall survival
- Secondary Outcome Measures
Name Time Method