BC2001

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.

Results

View a lay summary of the BC2001 results prepared by CRUK.

Further information

Chief Investigator: Professor Nicholas James

ICR-CTSU Scientific Lead: Professor Emma Hall

Trial management contact: Hannah Gribble- Trial Manager ([email protected])

ISRCTN: 68324339

Sponsor: University of Birmingham

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

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

View BC2001 on the National Institute for Health Research website: NIHR - Be Part Of Research 

Patient friendly information on the BC2001 trial at Cancer Research UK

Publications and presentations

Choudhury C, Porta N, Hall E, Song YP, Owen R, MacKay R, West CML, Lewis R, Hussain SA, James ND, Huddart R, Hoskin P. Hypofractionated radiotherapy in locally advanced bladder cancer: an individual patient data meta-analysis of the BC2001 and BCON trials. Lancet Oncol. 2021;22(2):246-55.

Hussain SA, Porta N, Hall E, Salawu A, Lewis R, Sreenivasan T, Wallace J, Crundwell M, Jenkins P, Tremlett J, Huddart R, James ND. Outcomes in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Chemotherapy Followed by (Chemo)radiotherapy in the BC2001 Trial. Eur Urol. 2021;79(2):307-15.

Huddart R, Hall E, Lewis R, Porta N, Crundwell M, Jenkins P, Rawlings C, Tremlett J, Campani L, Hendron C, Hussain S, James N. Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial. Eur Urol. 2019;77(2)260-68. 

Walker AK, Karaszi K, Valentine H, Strauss VY, Choudhury A, McGill S, Wen K, Brown MD, Ramani V, Bhattarai S, Teo MTW, Yang L, Myers KA, Deshmukh N, Denley H, Browning L, Love SB, Iyer G, Clarke NW, Hall E, Huddart R, James ND,  Hoskin PJ, West CML, Kiltie AE. MRE11 as a predictive biomarker of outcome following radiotherapy in bladder cancer. Int J Radiat Oncol Biol Phys. 2019;104(4):809-18.

Choudhury A, West CM, Porta N, Hall E, Denley H, Hendron C, Lewis R, Hussain SA, Huddart R and James N. The predictive and prognostic value of tumour necrosis in muscle invasive bladder cancer patients receiving radiotherapy with or without chemotherapy in the BC2001 trial (CRUK/01/004). Br J Cancer. 2017;116(5):649-57.

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 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. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012;366(16):1477-88.