| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68324339 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BC2001 |
| Public title | 2x2 Factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Bladder (advanced) |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 18 or over
2. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional or squamous cell carcinoma)
3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a, N0, M0)
4. Patients with multiple tumours at the time of randomisation are not eligible for the radiotherapy volume randomisation but may be randomised to whole bladder radiotherapy with or without chemotherapy
5. World Health Organisation (WHO) performance status 0-2 Leucocytes >4.0 x 10(9)/ l; Platelets >100 x 10(9)/l Glomerular filtration rate (GFR) >25 ml/min Serum bilirubin <1.5 upper limit of reference range (ULRR) alanine amino transferase (ALT) or aspartate amino transferase (AST) <1.5 x ULRR
6. Patient available for long term follow up and in the opinion of the investigator, able to receive radical radiotherapy
7. Patients written informed consent
8. Able to understand and complete the QoL questionnaire (patient can enter study without QoL but ALL are invited) |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 03/08/2001 |
| Anticipated end date | 31/08/2011 |
| Status of trial | Ongoing |
| Target number of participants | Not provided at time of registration. |
| Interventions | Four possible randomisations as follows:
1. Synchronous 5-Fluorouracil (5-FU) and Mitomycin with standard radiotherapy (to the whole bladder)
2. Synchronous 5-FU and Mitomycin with whole bladder volume radiotherapy
3. Standard radiotherapy to the whole bladder and no chemotherapy
4. Whole bladder volume radiotherapy and no chemotherapy |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Cancer Research UK |
| Sponsor name | Individual Sponsor (UK) |
| Sponsor details | Prof Nick James
Queen Elizabeth Hospital
Clinical Trials Unit
Edgbaston
Birmingham
United Kingdom
B15 2TH |
| Sponsor telephone | +44 (0)20 8722 4058 |
| Sponsor fax | +44 (0)20 8770 7876 |
| Sponsor email | Kathryn.Briggs@icr.ac.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Ms Kathyrn Briggs |
| Contact details | Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton, Surrey
United Kingdom
SM2 5NG |
| Contact telephone | +44 (0)20 8722 4058 |
| Contact fax | +44 (0)20 8770 7876 |
| Contact email | Kathryn.Briggs@icr.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68324339 |
| Date last extracted from ISRCTN register | 17/04/2008 |
