Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00033436
Protocol/serial number
BCON
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
carbogen
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2000
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2000
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Reseach UK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 early results in http://www.ncbi.nlm.nih.gov/pubmed/18992952
Publication citations
-
Early results
Hoskin PJ, Rojas AM, Saunders MI, Bentzen SM, Motohashi KJ, , Carbogen and nicotinamide in locally advanced bladder cancer: early results of a phase-III randomized trial., Radiother Oncol, 2009, 91, 1, 120-125, doi: 10.1016/j.radonc.2008.10.001.