Advanced or metastatic biliary tract cancer Cancer Malignant neoplasm of other and unspecified parts of biliary tract
Conditions
Interventions
Randomisation between:
Arm A: Biliary stenting alone
Arm B: Biliary stenting plus photodynamic therapy
Please note that as of 18/01/10 this trial is closed to recruitment.
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 16 years of age, either sex 2. Histologically/cytologically confirmed biliary tract carcinoma, unsuitable for surgery 3. Adequate biliary drainage 4. World Health Organization (WHO) performance score of 0, 1, 2 or 3 5. Life expectancy of greater than 12 weeks
Exclusion criteria
Exclusion criteria: 1. Receiving concurrent treatment for metastatic disease 2. Other/prior malignancy or intercurrent disease 3. Unable to give consent 4. Shows symptoms of porphyria 5. Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, i.e. death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival, measured by means of CT scanning carried out every three months until evidence of progression is identified 2. Toxicity, collected at baseline and 1 month post trial treatment for patients on the PDT arm we also collect toxicity data 7 days post-PDT treatment 3. Quality of life, collected at baseline 1, 3 and 6 months post-trial treatment | — |
Countries
England, United Kingdom
Outcome results
None listed