Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
04/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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

http://www.icr.ac.uk

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

  1. 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.

Additional files

Editorial Notes