A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer
ISRCTN | ISRCTN45938399 |
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DOI | https://doi.org/10.1186/ISRCTN45938399 |
ClinicalTrials.gov number | NCT00033436 |
Secondary identifying numbers | BCON |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 28/10/2021
- 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 of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
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 | Treatment |
Scientific title | A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Bladder (advanced) |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | carbogen |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/10/2000 |
Completion date | 31/12/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/10/2000 |
Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Reseach UK
No information available
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? |
---|---|---|---|---|---|
Results article | early results | 01/04/2009 | Yes | No | |
Results article | 10-year results | 06/03/2021 | 11/03/2021 | Yes | No |
Plain English results | 28/10/2021 | No | Yes |
Editorial Notes
28/10/2021: Cancer Research UK plain English results link added.
11/03/2021: Publication reference added.
27/09/2017: internal review.