A randomised comparison of ten versus three fractions of radiotherapy for palliation in patients unsuitable for radical radiotherapy or chemotherapy

ISRCTN ISRCTN56736625
DOI https://doi.org/10.1186/ISRCTN56736625
Secondary identifying numbers BA09
Submission date
28/02/2001
Registration date
28/02/2001
Last edited
11/09/2007
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 Barbara Uscinska
Scientific

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 typeNot Specified
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer
InterventionTwo palliative radiotherapy schedules in patients with bladder cancer considered unsuitable for radical radiotherapy or chemotherapy
Intervention typeOther
Primary outcome measureChange in bladder and bowel symptoms at three months, quality of life, response, survival.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1992
Completion date01/11/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants500
Key inclusion criteriaLife expectancy of at least three months, no planned administration of cytotoxic chemotherapy
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/1992
Date of final enrolment01/11/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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 plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 01/05/2000 Yes No