Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BA09
Study information
Scientific title
Acronym
Study hypothesis
To compare the efficacy and side effects of two palliative radiotherapy schedules in patients with bladder cancer considered unsuitable for radical radiotherapy or chemotherapy.
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
Cancer
Intervention
Two palliative radiotherapy schedules in patients with bladder cancer considered unsuitable for radical radiotherapy or chemotherapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Change in bladder and bowel symptoms at three months, quality of life, response, survival.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1992
Overall trial end date
01/11/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Life expectancy of at least three months, no planned administration of cytotoxic chemotherapy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
500
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/1992
Recruitment end date
01/11/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
Publication citations
-
Results
Duchesne GM, Bolger JJ, Griffiths GO, Trevor Roberts J, Graham JD, Hoskin PJ, Fossâ SD, Uscinska BM, Parmar MK, A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09., Int. J. Radiat. Oncol. Biol. Phys., 2000, 47, 2, 379-388.