A randomised trial of radical radiotherapy in pT1g3 NXM0 bladder cancer
| ISRCTN | ISRCTN65282717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65282717 |
| ClinicalTrials.gov number | NCT00002490 |
| Secondary identifying numbers | BS06 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 29/10/2021
- 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
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
| none@provided.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised trial of radical radiotherapy in pT1g3 NXM0 bladder cancer |
| Study hypothesis | 1. To determine the efficacy of radical radiotherapy in reducing the incidence of progression of pT1G3 transitional cell carcinoma of the bladder to muscleinvasive disease and subsequent disease fatality. 2. To assess the toxicity of the radiotherapy. 3. To determine the incidence of carcinoma in situ elsewhere in the bladder and the influence of this on the subsequent clinical outcome. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Cancer |
| Intervention | 1. One group receives radical radiotherapy 2. The other group receives intravesical treatment with no radiotherapy |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1991 |
| Overall study end date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Total final enrolment | 210 |
| Participant inclusion criteria | 1. A new diagnosis of pT1G3 NXMO tumour or tumours made within 6 months of randomisation. (A prior history of bladder tumours of a lower stage or grade is admissible) 2. No history of urothelial tumours of a higher stage 3. Muscle from the base of tumour is histologically clear 4. Widespread Carcinoma In Situ (CIS) causing severe symptoms is not admissible 5. No clinical, radiological or biochemical evidence of distant metastases 6. No prior therapy with intravesical chemotherapy or BCG other than a single adjuvant treatment 7. No concomitant or previous malignancy other than non-melanomatous skin cancer or cervical intraepithelial neoplasia (CIN) 8. WHO performance status of 0-2 9. Complete resection of all tumours 10. Deemed suitable to undergo radiotherapy and cystoscopy follow-up |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/09/1991 |
| Recruitment end date | 30/04/2003 |
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 (MRC) (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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 01/06/2005 | No | No | ||
| Results article | results | 01/09/2007 | Yes | No | |
| Plain English results | 08/09/2009 | 29/10/2021 | No | Yes |
Editorial Notes
29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
