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ISRCTN
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ISRCTN45938399
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ClinicalTrials.gov identifier
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Public title
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A multicentre randomised trial of radical radiotherapy with carbogen in the radical radiotherapy of locally advanced bladder cancer
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Scientific title
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Acronym
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N/A
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Serial number at source
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BCON
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bladder (advanced)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2000
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cancer Reseach UK
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Cancer Research UK (CRUK) (UK)
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Address
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PO Box 123
Lincoln's Inn Fields
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City/town
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London
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Zip/Postcode
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WC2A 3PX
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Country
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United Kingdom
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Tel
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+44 (0)20 7317 5186
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Fax
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+44 (0)20 7487 4302
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Email
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kate.law@cancer.org.uk
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Sponsor website:
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http://www.cancer.org.uk
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Date applied
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01/07/2001
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Last edited
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28/04/2008
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Date ISRCTN assigned
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01/07/2001
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