A Trial of Accelerated Fractionation in Localised Invasive Bladder Cancer

ISRCTN	ISRCTN82138783
DOI	https://doi.org/10.1186/ISRCTN82138783
Protocol serial number	ICR/CUCG
Sponsor	The Institute of Cancer Research (UK)
Funder	Institute of Cancer Research (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1998

Participant type(s)	Patient
Age group	Not Specified
Sex
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1988
Date of final enrolment	31/12/1998

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2005		Yes	No