A randomised trial of radical radiotherapy in pT1g3 NXM0 bladder cancer
- Conditions
- CancerBladder cancer
- Registration Number
- ISRCTN65282717
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
2005 Abstract results in https://ascopubs.org/doi/abs/10.1200/jco.2005.23.16_suppl.4505 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17631326 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration