Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR/CUCG
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
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Bladder (advanced)
Intervention
1. Schedule A: Radiotherapy, an accelerated fractionation schedule of 60.8 Gy given in thirty-two fractions over 26 days. Radiotherapy is given twice daily (morning dose of 1.8 Gy and 2.0 Gy in the afternoon) as 22.8 Gy in twelve fractions over 8 days, followed by a 3 to 6 day gap, followed by 38 Gy in twenty fractions over 2 weeks.
2. Schedule B: Radiotherapy, a conventional fractionation schedule of 64 Gy given in thirty-two fractions over 6.5 weeks. Radiotherapy is given once per day 5 days per week.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1988
Overall trial end date
31/12/1998
Reason abandoned
Eligibility
Participant inclusion criteria
1. Stage T2 or T3 NXMO carcinoma of the bladder defined either by clinical findings or by histopathology
2. If nodes are assessed N1 patients (single node <2 cm) are eligible, N2 and N3 patients are excluded
3. Patients with severe concurrent general medical illness especially those with inflammatory bowel disease, other malignancies (except skin cancer), recent myocardial infarction (within 3 months) or previous major pelvic surgery are excluded
Participant type
Patient
Age group
Not Specified
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
01/01/1988
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Institute of Cancer Research (UK)
Alternative name(s)
l'Institut du cancer, Institut du Cancer, ICR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
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
2005 results on http://www.ncbi.nlm.nih.gov/pubmed/15878099
Publication citations
-
Results
Horwich A, Dearnaley D, Huddart R, Graham J, Bessell E, Mason M, Bliss J, A randomised trial of accelerated radiotherapy for localised invasive bladder cancer., Radiother Oncol, 2005, 75, 1, 34-43, doi: 10.1016/j.radonc.2004.11.003.