2x2 factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer

ISRCTN	ISRCTN68324339
DOI	https://doi.org/10.1186/ISRCTN68324339
ClinicalTrials.gov (NCT)	NCT00024349
Protocol serial number	BC2001
Sponsor	Individual Sponsor (UK)
Funder	Cancer Research UK

Submission date: 01/07/2001
Registration date: 01/07/2001
Last edited: 18/05/2022

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

Ms Rebecca Lewis
Scientific

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 (0)20 8722 4081
Email	Rebecca.Lewis@icr.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	2x2 factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer
Study objectives	Added 31/05/2011: Study hypothesis: BC2001 is a multi-centred randomised controlled trial which aims: 1. To investigate the efficacy and toxicity of synchronous chemo-radiotherapy in conservative management of invasive bladder cancer compared to radiotherapy alone. 2. To investigate whether modifying the volume of bladder irradiated by the full dose of radiotherapy can reduce toxicity of radiotherapy in the conservative treatment of invasive bladder cancer, without impacting on local control.
Ethics approval(s)	North West 5 Research Ethics Committee, 05/03/2001, ref: MREC 00/8/075
Health condition(s) or problem(s) studied	Bladder (advanced)
Intervention	Four possible randomisations as follows: 1. Synchronous 5-Fluorouracil (5-FU) and Mitomycin with standard radiotherapy (to the whole bladder) 2. Synchronous 5-FU and Mitomycin with whole bladder volume radiotherapy 3. Standard radiotherapy to the whole bladder and no chemotherapy 4. Whole bladder volume radiotherapy and no chemotherapy
Intervention type	Mixed
Primary outcome measure(s)	Added 02/06/2011: Loco-regional (Ui.e. pelvic nodes & bladderU) disease free survival. The particular time point of interest is 2 years post randomisation
Key secondary outcome measure(s)	Secondary endpoint: Disease free survival, Metastases free survival, Late toxicity at 1 and 2 years as assessed by RTOG and Lent Som toxicity scores, bladder capacity and Fact-BL QoL score. This endpoint is of particular importance in the radiotherapy comparison. Tertiary endpoints: 1. Acute toxicity 2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation 3. Rate of salvage cystectomy 4. Overall survival
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	350
Total final enrolment	458
Key inclusion criteria	1. Aged 18 or over 2. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional or squamous cell carcinoma) 3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a, N0, M0) 4. Patients with multiple tumours at the time of randomisation are not eligible for the radiotherapy volume randomisation but may be randomised to whole bladder radiotherapy with or without chemotherapy 5. World Health Organisation (WHO) performance status 0-2 Leucocytes >4.0 x 10(9)/ l; Platelets >100 x 10(9)/l Glomerular filtration rate (GFR) >25 ml/min Serum bilirubin <1.5 upper limit of reference range (ULRR) alanine amino transferase (ALT) or aspartate amino transferase (AST) <1.5 x ULRR 6. Patient available for long term follow up and in the opinion of the investigator, able to receive radical radiotherapy 7. Patients written informed consent 8. Able to understand and complete the QoL questionnaire (patient can enter study without QoL but ALL are invited)
Key exclusion criteria	1. Uncontrolled systemic disease which would preclude the patient from the study 2. Pregnancy 3. Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri) 4. Previous malignancy that is likely to interfere with protocol treatment 5. Inflammatory bowel disease 6. Previous pelvic radiotherapy 7. Bilateral hip replacements compromising accurate radiotherapy planning
Date of first enrolment	03/08/2001
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)

Sutton
SM2 5NG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/04/2012		Yes	No
Results article	results	01/10/2013		Yes	No
Results article	results	01/01/2015		Yes	No
Results article		13/05/2022	18/05/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/05/2022: Publication reference and total final enrolment added.
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)