Allopurinol in the prevention of superficial bladder tumour recurrence
| ISRCTN | ISRCTN65811336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65811336 |
| Secondary identifying numbers | 06/Q2501/64 |
- Submission date
- 01/05/2006
- Registration date
- 17/08/2006
- Last edited
- 09/01/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Leyshon Griffiths
Scientific
Scientific
Clinical Sciences Unit
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 (0) 116 258 4617 |
|---|---|
| trlg1@le.ac.uk |
Study information
| Study design | A single centre, randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Allopurinol in the prevention of superficial bladder tumour recurrence |
| Study acronym | RAPOR |
| Study objectives | Allopurinol reduces the risk of recurrence of superficial bladder cancer. |
| Ethics approval(s) | Being considered for approval by the Nottingham REC 2 (reference: UHL 9950 ETHICS 06/Q2501/64), final approval received 03/05/2006. |
| Health condition(s) or problem(s) studied | Superficial transitional cell carcinoma of the urinary bladder |
| Intervention | Allopurinol 100 mg once daily with food or placebo drug |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Allopurinol |
| Primary outcome measure | Time to biopsy-proven bladder tumour recurrence whilst taking allopurinol 100 mg once daily or placebo. |
| Secondary outcome measures | To evaluate the tolerability of allopurinol in patients with superficial bladder cancer, and to identify any adverse events. |
| Overall study start date | 01/06/2006 |
| Completion date | 01/01/2016 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 64 (60 at time of registration) |
| Key inclusion criteria | 1. Patients with solitary Transitional Cell Carcinoma (TCC) Ta or T1 bladder tumour (Grade one to two) that recurs at three months 2. Patients with multifocal TCC Ta bladder tumours (Grade one to two) that do not recur at three months 3. Patients with multifocal TCC Ta bladder tumours (Grade one to two) that recurs at three months |
| Key exclusion criteria | 1. Tumours with a higher risk of progression to muscle-invasive bladder cancer 2. Non-TCC bladder cancer 3. Multifocal T1 or Grade three TCC 4. Carcinoma in situ 5. More than one instillation of intravesical chemotherapy 6. Intravesical Bacillus Calmette-Guerin (BCG) therapy Other reasons: 1. Current azathioprine or mercaptopurine treatment 2. Serum creatinine more than 200 µmol/l 3. Pregnant 4. Breast feeding 5. Aged under 18 year of age 6. Previous Allopurinol hypersensitivity 7. Current allopurinol treatment |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Sciences Unit
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
Leicester General Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Research and Development
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0) 116 258 4199 |
|---|---|
| djr8@le.ac.uk | |
"ROR" |
https://ror.org/02zg49d29 |
Funders
Funder type
Government
University Hospitals of Leicester NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/01/2017: This trial has been marked as stopped as it was closed due to slow recruitment.
24/03/2011: The anticipated end date for this trial has been updated from 01/06/2008 to 01/01/2016.
