A randomised trial of intravesical thiotepa versus no intravesical chemotherapy
| ISRCTN | ISRCTN57776460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57776460 |
| Secondary identifying numbers | BS01 |
- Submission date
- 13/03/2001
- Registration date
- 13/03/2001
- Last edited
- 11/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Danielle Andrews
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. To detect any effect of intravesical instillation of Thiotepa on the recurrence rate of superficial bladder cancer 2. To detect any extra effect of repeating instillations of Thiotepa at follow-up cytoscopy during the first year on the recurrence rate of superficial bladder cancer 3. To assess the effect of the presence of urothelial atypism or carcinoma in random biopsies on the recurrence rate of superficial bladder cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Intravesical thiotepa versus no intravesical chemotherapy |
| Intervention type | Other |
| Primary outcome measure | 1. Time to first superficial 2. Recurrence rate (number of positive cytoscopies per annum) 3. Failure-free survival rate |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1981 |
| Completion date | 31/12/1991 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 417 |
| Key inclusion criteria | 1. Newly diagnosed superficial carcinoma of the bladder suitable for complete endoscopic resection 2. World Health Organisation (WHO) performance status 0-2 3. Expected survival at least 3 years 4. White count >3 x 10^9/L and platelets >100 x 10^9/L 5. No history of other malignant tumours 6. No untreated urinary tract infection |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1981 |
| Date of final enrolment | 31/12/1991 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/1994 | Yes | No |
