A randomised, phase III, placebo-controlled trial evaluating the addition of celecoxib to standard treatment of transitional cell carcinoma of the bladder.
Disease site: Bladder cancer, urological cancers
Treatment modality: Systemic therapy
Status: In follow up
BOXIT is a randomised, phase III, multicentre, double blind, placebo controlled clinical trial to determine if addition of the oral COX-2 inhibitor celecoxib to standard therapy is more effective in terms of disease recurrence at 3 years compared to standard therapy alone for the treatment of non-muscle invasive transitional cell carcinoma of the bladder in intermediate and high risk patients.
472 patients were recruited from UK sites over a 5 year period. Patients received either 400 mg celecoxib daily for 2 years or placebo, in addition to standard therapy, and are being followed up for up to 10 years.
We have prepared a lay summary of the BOXIT results, which can be viewed and downloaded here.
The trial results have also been published in European Urology.
Chief Investigator: Professor John Kelly, University College London
ICR-CTSU Scientific Lead: Professor Emma Hall
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: Cancer Research UK (CRUK/07/04), with additional funding in the form of educational grants provided by Kyowa Hakko UK Limited and Cambridge Laboratories Limited. Celecoxib supplied free of charge by Pfizer, Inc.
Further information including recruitment progress is available from the UK Clinical Trials Gateway
Patient friendly information is available from Cancer Research UK
Publications and presentations
Kelly JD, Tan WS, Mostafid A, Huddart R, Protheroe A, Bogle R, Blazeby J, Palmer A, Cresswell J, Johnson M, Brough R, Madaan S, Andrews S, Cruickshank C, Burnett S, Maynard L, Hall E; on behalf of the BOXIT Investigators. BOXIT—A Randomised Phase III Placebo-controlled Trial Evaluating the Addition of Celecoxib to Standard Treatment of Transitional Cell Carcinoma of the Bladder (CRUK/07/004). Eur Urol. (2018).
Kelly JD, Maynard L, Mostafid A, Huddart R, Bogle R, Cresswell J, Johnson M, Protheroe A, Burnett S, Hall E; on behalf of the BOXIT Trial Management Group. 2015. Celecoxib for the treatment of non-muscle invasive bladder cancer (NMIBC): results of the randomised BOXIT trial (CRUK/07/004). BJU Int 2015;115(Suppl 7):11 #8.
Blazeby JM, Hall E, Aaronson NK, Lloyd L, Waters R, Kelly JD, Fayers P. Validation and reliability testing of the EORTC QLQ-NMIBC24 questionnaire module to assess patient-reported outcomes in non-muscle-invasive bladder cancer. Eur Urol. 2014;66(6):1148-56.
Mostafid A, Hall E, Burnett S, Protheroe A, Kelly J; on behalf of the BOXIT. Compliance with intravesical therapy guidelines for intermediate and high risk non muscle invasive bladder cancer patients in the UK. Poster presented at: British Association of Urological Surgeons Section of Oncology Meeting; 2012 November; Belfast.
Briggs K, Ireland E, A'Hern R, Kelly J; on behalf of the BOXIT Protocol Development Group. Does inhibition of the COX-2 enzyme reduce recurrence of transitional cell carcinoma (TCC) of the bladder when given to patients receiving standard therapy? The BOXIT trial. Presented at: 2nd National Cancer Research Institute Cancer Conference; 2006 Oct 8-11; Birmingham UK.