A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer

ISRCTN ISRCTN45938399
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBladder (advanced)
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)carbogen
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2000
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/10/2000
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.