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BC2001

BC2001 is a randomised phase III study of radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer.

Disease site: Urological  Bladder cancer

Treatment modality: Chemotherapy and Radiotherapy

Status: In active follow-up

Trial details

BC2001 is a randomised phase III study of radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer. It aims to investigate, in the conservative management of invasive bladder cancer, the efficacy and toxicity of synchronous chemo-radiotherapy compared to radiotherapy alone, and whether modifying the volume of bladder treated by 'full dose' radiotherapy can reduce toxicity. The trial opened to recruitment in August 2001, the radiotherapy comparison closed in 2006 and the chemotherapy comparison closed in April 2008. A total of 458 patients were recruited.

Chief Investigator: Professor Nicholas James, University of Birmingham

ICR-CTSU Scientific Lead: Dr Emma Hall

Trial management contact: Rebecca Lewis - Senior Trial Manager, [email protected]

ISRCTN: 68324339

Sponsor: University of Birmingham

Funding: Cancer Research UK (CRUK/01/004)

Further information

Further information on the BC2001 trial may be found on the following sites:

Monthly accrual figures are available from the UK Clinical Trials Gateway

Patient friendly information on the BC2001 trial at CancerHelp UK

Publications and presentations 

Huddart RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND. Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004). Int J Radiat Oncol Biol Phys. 2013;87(2):261-9.

James N, Hussain S, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Lewis R, Hendron C, Waters R, Huddart R. Results of BC2001: 2x2 phase III randomised trial of synchronous chemo-radiotherapy (CRT) compared to radiotherapy (RT) alone and standard (sRT) versus reduced high-dose volume RT (rvRT) in muscle invasive bladder cancer (MIBC) (CRUK/01/004). NCRI National Cancer Conference; 2010; Liverpool.

James N, Hussain S, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Waters R, Huddart RA. Results of a 2 x 2 Phase III Randomized Trial of Synchronous Chemo-radiotherapy (CRT) Compared to Radiotherapy (RT) Alone and Standard vs. Reduced High Volume RT in Muscle Invasive Bladder Cancer (MIBC) (BC2001 CRUK/01/004). Int. J. Radiat. Oncol. Biol. Phys. 2010;78(3 Supplement 1):S2 -S3

James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Hendron C, Lewis R, Rogers S, Huddart RA, on behalf of the BC2001 Investigators. Results of a phase III randomized trial of synchronous chemoradiotherapy (CRT) compared to radiotherapy (RT) alone in muscle-invasive bladder cancer (MIBC) (BC2001 CRUK/01/004). J. Clin. Oncol. 2010;28(15_suppl):4517

Huddart R, James N, Adab F, Syndikus I, Jenkins P, Rawlings C, Rogers S, Lewis R, Hendron C, Hussain S, Hall E. Updated results of the BC2001 phase III randomised trial of standard vs reduced high dose volume radiotherapy for muscle invasive bladder cancer:tumour control, toxicity and quality of life. Eur J Cancer Supplements 2009;7(2):423

Huddart RA, James ND, Adab F, Syndikus I, Jenkins P, Rawlings C, Hendron C, Lewis R, Rogers S, Hall E, on behalf of the BC2001 Investigators. BC2001: A multicenter phase III randomized trial of standard versus reduced volume radiotherapy for muscle invasive bladder cancer (ISCRTN:68324339). J. Clin. Oncol. 2009;27(15S):5022

Huddart R, Hall E, James N, Hussain S, Crundwell M, Jenkins P, Rawlings C, Rogers S. Effect of reducing radiotherapy volume of bladder toxicity: First report of the BC2001 trial: a multicentre phase III randomised trial of standard versus reduced volume radiotherapy trial ISCRTN No. 68324339. Radiother. Oncol. 2008;88(Supplement 2):S19

Huddart R, Hall E, James N, Hussain S, Crundwell M, Tremlett J, Jenkins P, Rawlings C, Rogers S. BC2001: a multicentre phase III randomised trial of synchronous chemotherapy versus no chemotherapy and standard versus reduced volume radiotherapy in muscle invasive bladder cancer. NCRI National Cancer Conference; Oct 2008; Birmingham. NCRI.

Huddart RA, Hall E, James N, Crundwell M, Tremlett J, Jenkins P, Rawlings C, Rogers S. Effect of Reducing Radiotherapy Volume on Bladder Toxicity: First Report of the BC2001 Trial; A Multicenter Phase III Randomized Trial of Standard versus Reduced Volume Radiotherapy Trial Iscrtn No. 68324339, Eudract No. 2004-000164-26. Int. J. Radiat. Oncol. Biol. Phys. 2008;72(1 Supplement 1):S292-S93

Huddart RA, Hall E, James N, Crundwell M, Tremlett J, Jenkins P, Rawlings C, Rogers S. Effect of Reducing Radiotherapy Volume on Bladder Toxicity: First Report of the BC2001 Trial; A Multicenter Phase III Randomized Trial of Standard versus Reduced Volume Radiotherapy Trial Iscrtn No. 68324339, Eudract No. 2004-000164-26. Radiother. Oncol. 2008;88(Supplement 2):S19

James N, Hussain S, Rawlings C, Jenkins O, Tremlett J, Crundwell M, Huddart R, Hall E, Rogers S. First toxicity report ot the BC 2001 trial; a multicentre phase III randomised trial of radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer. Radiother. Oncol. 2008;88(2):S298

James N, Hussain S, Rawlings C, Jenkins P, Tremlett J, Crundwell M, Huddart R, Hall E, Rogers S. BC2001; a multicentre phase III randomised trial of standard versus reduced volume radiotherapy trial, with and without synchronous chemotherapy in muscle invasive bladder cancer. NCRI National Cancer Conference; Oct 2008; Birmingham. NCRI.

James ND, Hussain SA, Tremlett J, Crundwell M, Jenkins P, Rawlings C, Hall E, Rogers S, Huddart R. First Toxicity Report of the BC2001 Trial: A Multicentre Phase III Randomised Trial of Radiotherapy with and without Synchronous Chemotherapy in Muscle Invasive Bladder Cancer ISCRTN No. 68324339, EUDRACT No. 2004-000164-26. Int. J. Radiat. Oncol. Biol. Phys. 2008;72(1 Supplement 1):S7

Huddart R, Hall E, Hussain S, Denholm EE, Mount R, James N, on behalf of the ABC Trial Management Group. BC2001 - a randomised trial of chemo-radiotherapy in bladder cancer. Clin. Oncol. (R. Coll. Radiol). 2002;14:S48 #D1.1

Clinical trials

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The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.

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