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2x2 Factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer
DOI 10.1186/ISRCTN68324339
ClinicalTrials.gov identifier NCT00024349
EudraCT number
Public title 2x2 Factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer
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
Acronym N/A
Serial number at source BC2001
Study hypothesis Added 31/05/2011:
Study hypothesis: BC2001 is a multi-centred randomised controlled trial which aims:
a) To investigate the efficacy and toxicity of synchronous chemo-radiotherapy in conservative management of invasive bladder cancer compared to radiotherapy alone.
b) 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.

Please note, as of 02/06/2011 updates have been made to this trial record. These can be found under this date in the relevant sections below.
Lay summary Not provided at time of registration
Ethics approval North West 5 Research Ethics Committee 05/03/2001 (ref: MREC 00/8/075)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Bladder (advanced)
Participants - 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)
Participants - 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
Anticipated start date 03/08/2001
Anticipated end date 31/08/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 350 (Added 02/06/2011)
Interventions 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
Primary outcome measure(s) Loco-regional (Ui.e. pelvic nodes & bladderU) disease free survival. The particular time point of interest is 2 years post randomisation. (Added 02/06/2011)
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
Sources of funding Cancer Research UK
Trial website http://www.bc2001.bham.ac.uk/
Publications 1. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22512481
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23958147
Contact name Ms  Rebecca  Lewis
  Address Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
  City/town Sutton, Surrey
  Zip/Postcode SM2 5NG
  Country United Kingdom
  Tel +44 (0)20 8722 4081
  Fax +44 (0)20 8770 7876
  Email Rebecca.Lewis@icr.ac.uk
Sponsor Individual Sponsor (UK)
  Address Prof Nick James
Queen Elizabeth Hospital
Clinical Trials Unit
  City/town Birmingham
  Zip/Postcode B15 2TH
  Country United Kingdom
  Tel +44 (0)121 414 4097
  Email N.D.James@bham.ac.uk
  Sponsor website: http://www.cancer.org.uk
Date applied 01/07/2001
Last edited 05/11/2013
Date ISRCTN assigned 01/07/2001
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