A Trial of Accelerated Fractionation in Localised Invasive Bladder Cancer

ISRCTN ISRCTN82138783
DOI https://doi.org/10.1186/ISRCTN82138783
Secondary identifying numbers ICR/CUCG
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
04/01/2012
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 - -
Scientific

UKCCCR Register Co-ordinator
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)Hospital
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBladder (advanced)
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1988
Completion date31/12/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1988
Date of final enrolment31/12/1998

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

The Institute of Cancer Research (UK)
Government

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website http://www.icr.ac.uk
ROR logo "ROR" https://ror.org/043jzw605

Funders

Funder type

Research organisation

Institute of Cancer Research (UK)
Government organisation / National government
Alternative name(s)
Institute of Cancer Research - CIHR, CIHR Institute of Cancer Research, L'Institut du cancer, Institut du cancer, ICR - CIHR, ICR, IC
Location
Canada

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 01/04/2005 Yes No