Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
NCT ID: NCT00024349
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2001-06-30
2012-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to all or part of the bladder with or without chemotherapy in treating patients who have stage II or stage III bladder cancer.
Detailed Description
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* Compare the efficacy of standard volume radiotherapy vs reduced volume radiotherapy with or without synchronous fluorouracil and mitomycin in patients with stage II or III (muscle invasive) bladder cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior neoadjuvant chemotherapy (yes vs no), and intent to enter only 1 of the possible 2 randomizations on study (yes vs no). Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo standard radiotherapy once daily 5 days a week for 4 or 6.5 weeks. Patients also receive synchronous chemotherapy comprising mitomycin IV on day 1 and fluorouracil IV continuously over days 1-5 and 16-20 during radiotherapy.
* Arm II: Patients undergo standard radiotherapy as in arm I (without chemotherapy).
If standard radiotherapy is clearly indicated (e.g., patients with multiple tumors) patients may be randomized to standard radiotherapy with or without chemotherapy (arms I or III above). If chemotherapy is clearly contraindicated, patients are randomized to standard or reduced volume radiotherapy without chemotherapy (arms III or IV above).
Quality of life is assessed at baseline, at the end of therapy, at 6 and 12 months post-randomization, and then annually for at least 5 years.
Patients are followed at 6, 9, and 12 months post-randomization and then at least annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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fluorouracil
mitomycin C
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive bladder cancer (T2-4a, N0, M0)
* Adenocarcinoma
* Transitional cell carcinoma
* Squamous cell carcinoma
* Localized muscle invasion by surgery or imaging
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 4,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* ALT or AST less than 1.5 times ULN
Renal:
* Glomerular filtration rate greater than 25 mL/min
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No inflammatory bowel disease
* No other prior malignancy within the past 2 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No other prior malignancy or uncontrolled systemic disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to the pelvis
Surgery:
* See Disease Characteristics
* No bilateral hip replacements
Other:
* No concurrent metronidazole during fluorouracil administration
18 Years
ALL
No
Sponsors
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University Hospital Birmingham
OTHER
Principal Investigators
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Nicholas D. James, MD
Role: STUDY_CHAIR
University Hospital Birmingham
Locations
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Royal United Hospital
Bath, England, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Royal Bournemouth Hospital NHS Trust
Bournemouth, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Cheltenham General Hospital
Cheltenham, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
St. Thomas' Hospital
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Good Hope Hospital Trust
West Midlands, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom
Countries
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References
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James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA; BC2001 Investigators. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012 Apr 19;366(16):1477-88. doi: 10.1056/NEJMoa1106106.
Choudhury A, Porta N, Hall E, Song YP, Owen R, MacKay R, West CML, Lewis R, Hussain SA, James ND, Huddart R, Hoskin P; BC2001 and BCON investigators. Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials. Lancet Oncol. 2021 Feb;22(2):246-255. doi: 10.1016/S1470-2045(20)30607-0.
Other Identifiers
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CRC-BC2001
Identifier Type: -
Identifier Source: secondary_id
EU-20052
Identifier Type: -
Identifier Source: secondary_id
ISRCTN68324339
Identifier Type: -
Identifier Source: secondary_id
CDR0000068921
Identifier Type: -
Identifier Source: org_study_id