| Source of record | UK Trials |
| ISRCTN | ISRCTN45938399 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BCON |
| Public title | A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| 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 transitional cell carcinoma of the bladder
3. Muscle invasive carcinoma (Stage T2 or T3) of any grade; G3 superficial bladder cancer (T1) or prostatic invasion T4a
4. Ability to give informed consent
5. Capable of complying with the use of a closed breathing system delivering carbogen through either a mask or a mouthpiece with nasal clip
6. No squamous or adenocarcinoma of the bladder
7. No locally advanced T4b carcinoma
8. No presence of distant metastasis or enlarged lymph nodes on Computed Tomography (CT) staging scan of the pelvis
9. No co-existing respiratory disease that contra-indicates delivery of 95% oxygen
10. No impaired renal or hepatic function
11. No ischeamic heart disease or peripheral vascular disease requiring treatment with diuretics or ACE inhibitors |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/10/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive Radiotherapy: Either 55 Gy in 20 daily fractions Or 64 Gy in 32 daily fractions. Treatments will be given daily five times per week treating all fields daily.
Patients are then randomised to:
1. Control (no further treatment)
2. Carbogen 2% CO2 (Carbogen will be delivered through a closed breathing system at a flow rate of 15 L/min of carbogen, to commence 5 min before delivery of radiation, and to commence throughout treatment) plus Nicotinamide: 60 mg/kg taken orally 1.5-2 hours before radiation |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Reseach UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN45938399 |
| Date last extracted from ISRCTN register | 17/04/2008 |
