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
Protocol serial number BA09
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
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 measure(s)

Change in bladder and bowel symptoms at three months, quality of life, response, survival.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/11/1997

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration500
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

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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