Radiation Therapy With or Without Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
2X2 Factorial Randomized Phase III Study Comparing Standard Versus Reduced Volume Radiotherapy With and Without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer
4 other identifiers
interventional
350
1 country
27
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy such as fluorouracil and mitomycin use different ways to stop tumor cells from dividing so they stop growing or die. Fluorouracil and mitomycin may make the tumor cells more sensitive to radiation therapy. It is not yet known if radiation therapy is more effective with or without chemotherapy in treating bladder cancer. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2001
Longer than P75 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 18, 2013
May 1, 2007
September 13, 2001
December 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loco-regional disease free survival at 2 years
Secondary Outcomes (4)
Disease-free survival, metastases-free survival, and late toxicity by RTOG and Lent Som toxicity scores, Bladder capacity, and patient assessed Fact-BL quality of life scores at 1 and 2 years
Acute toxicity and cystoscopic local control at 3 months, 1 year, and 2 years
Rate of salvage cystectomy
Overall survival
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (27)
Royal United Hospital
Bath, England, BA1 3NG, United Kingdom
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH, United Kingdom
Royal Bournemouth Hospital NHS Trust
Bournemouth, England, BH7 7DW, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BF, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ, United Kingdom
Cheltenham General Hospital
Cheltenham, England, GL53 7AN, United Kingdom
Essex County Hospital
Colchester, England, C03 3NB, United Kingdom
Walsgrave Hospital
Coventry, England, CV2 2DX, United Kingdom
Derbyshire Royal Infirmary
Derby, England, DE1 2QY, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, HU8 9HE, United Kingdom
St. Thomas' Hospital
London, England, SE1 9RT, United Kingdom
Maidstone Hospital
Maidstone, England, ME16 9QQ, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY, United Kingdom
James Cook University Hospital
Middlesbrough, England, TS4 3BW, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, NN1 5BD, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT, United Kingdom
Torbay Hospital
Torquay, England, TQ2 7AA, United Kingdom
Good Hope Hospital Trust
West Midlands, England, B75 7RR, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Worthing Hospital
Worthing, England, BN11 2DH, United Kingdom
Yeovil District Hospital
Yeovil, England, BA21 4AT, United Kingdom
Glan Clwyd Hospital
Rhyl, Wales, LL18 5UG, United Kingdom
Related Publications (2)
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.
PMID: 22512481RESULTChoudhury 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.
PMID: 33539743DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicholas D. James, MD
University Hospital Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2001
First Posted
January 27, 2003
Study Start
June 1, 2001
Study Completion
April 1, 2012
Last Updated
December 18, 2013
Record last verified: 2007-05