Topic: Cancer
Conditions
Interventions
Randomisation will be undertaken centrally using either the secure web-based or the 24-hour Interactive Voice Response randomisation system at the Centre for Healthcare Randomised Trials (CHaRT) in Ab
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged = 16 years 2. First suspected diagnosis of bladder cancer 3. Visual/ultrasound/CT diagnosis of intermediate/high risk NMIBC 3.1. White light visual appearances of intermediate or high risk disease (=> 3cm, two or more tumours, or flat velvety erythematous changes alerting a clinical suspicion of CIS). 3.2. Suspicion of papillary bladder tumour > 3cm based on ultrasound or computerized tomography (CT) scanning (without hydronephrosis) 4. Written informed consent for participation prior to any study specific procedures 5. Willing to comply with lifestyle guidelines
Exclusion criteria
Exclusion criteria: 1. Visual evidence of low risk NMIBC (solitary tumour 5 years upon trial entry) 6. Evidence of metastases 7. Porphyria or known hypersensitivity to porphyrins 8. Known pregnancy (based on history and without formal testing, in keeping with day-to-day NHS practice of PDD use) 9. Any other conditions that in the Principal Investigator?s opinion would contraindicate protocol treatment 10. Unable to provide informed consent 11. Unable or unwilling to complete follow up schedule (including questionnaires)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare time to recurrence, for each of the two treatment strategies, with a principal point of interest at 3 years. 2. To evaluate cost effectiveness by the incremental cost for recurrence avoided and cost utility as the incremental cost per quality adjusted life year (QALY) gained at three years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives will further explore clinical and cost effectiveness of photo dynamic surgery: Clinical effectiveness: 1. Measure relative rate of disease progression at 3 years 2. Measure relative harms and safety 3. Measure health-related quality of life (HRQoL) and cancer specific survival | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed