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 number	NCT00024349
Secondary identifying numbers	BC2001

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

Not provided at time of registration

Study website

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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 hypothesis	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
Condition	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	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
Secondary outcome measures	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
Overall study start date	03/08/2001
Overall study end date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	350 (Added 02/06/2011)
Total final enrolment	458
Participant 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)
Participant 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
Recruitment start date	03/08/2001
Recruitment end date	31/08/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

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

Sutton
SM2 5NG
United Kingdom

Sponsor information

Individual Sponsor (UK)
Other

Prof Nick James
Queen Elizabeth Hospital
Clinical Trials Unit
Edgbaston
Birmingham
B15 2TH
United Kingdom

Phone	+44 (0)121 414 4097
Email	N.D.James@bham.ac.uk
Website	http://www.cancer.org.uk

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
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

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)