Trial Information
A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
Inclusion Criteria:
- Written informed consent
- Age ≥18 years
- Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological
sub-type)
- Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason
(including performance status, co-morbidity, patient refusal)
- Expected survival >6 months
- WHO performance status 0-3
- Willing to undergo post treatment cystoscopy
Exclusion Criteria:
- Nodal or metastatic disease
- Concurrent malignancy
- Previous pelvic radiotherapy
- Urinary catheter in-situ
- Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)
- Unable to attend for post treatment follow up
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
Outcome Description:
Acute CTC non-genitourinary toxicity grade 3 or higher.
Outcome Time Frame:
12 weeks from start of radiotherapy
Safety Issue:
Yes
Principal Investigator
Robert Huddart
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Cancer Research/RMNHSFT
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CCR3973
NCT ID:
NCT01810757
Start Date:
January 2014
Completion Date:
January 2025
Related Keywords:
- Bladder Cancer
- Urinary Bladder Neoplasms