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CALIBER

Phase II randomised feasibility study of chemoresection and surgical management in low risk, non-muscle-invasive bladder cancer.

Disease site: Bladder cancerurological cancers

Treatment modality: Intravesical chemotherapy, surgery

Status: In follow up

Trial details

CALIBER is randomised, multicentre, phase II feasibility study investigating whether chemotherapy inside the bladder (chemoresection) could be a treatment option for people with recurrent low risk, non-muscle-invasive bladder cancer.

174 patients will be recruited from approximately 25 UK sites over 3 years. 116 patients will receive four once-weekly intravesical instillations of 40mg mitomycin C (chemoresection group) and 58 patients receiving the standard surgical management in use at their hospital for treatment of recurrence (surgical management control group).

The control group will provide prospective data about surgical management and outcomes and assess feasibility of recruitment to a randomised study. All participants will be followed up regularly during the first year after treatment and annually thereafter.

Results

We have prepared a lay summary of the CALIBER results, which can be viewed and downloaded here

Further information

Chief Investigator: Mr Hugh Mostafid, Royal Surrey County Hospital NHS Foundation Trust

ICR-CTSU Scientific Lead: Professor Emma Hall

Trial management contact: [email protected]

ISRCTN: 24855462

Sponsor: The Institute of Cancer Research

Funding: National Institute for Health Research – Research for Patient Benefit Programme

View CALIBER on the UK Clinical Trials Gateway.

Read a plain English summary of CALIBER from Cancer Research UK.

Publications and presentations

Mostafid AH, Cresswell J, Griffiths TLR, Kelly JD, Knight A, Catto JWF, Davenport K, Feber A, Knowles M, McGrath J, Cooke P, Masood S, Goubar A, Penegar S, Porta N, Wiley L, Lewis R, Hall E. Results of CALIBER: A phase II randomised feasibility trial of chemoablation versus surgical management in low risk non-muscle invasive bladder cancer. Presented at: 33rd Annual EAU Congress; 2018 March 16-20; Copenhagen, Denmark.

Penegar S, Lewis R, Catto JWF, Cresswell J, Griffiths TLR, Hill M, Kelly JD, Knight A, McGrath J, Wiley L, Mostafid H, Hall E. Recruitment aids for a phase II randomised trial in low risk bladder cancer. Trials 2017, 18(Suppl 1).

Penegar S, Lewis R, Catto JWF, Cresswell J, Griffiths TLR, Hill M, Kelly JD, Knight A, McGrath J, Wiley L, Mostafid H, Hall E. Recruitment aids for a phase II randomised trial in low risk bladder cancer. Poster presentation at: 4th International Clinical Trials Methodology Conference; 2017 May 7-10; Liverpool, UK.

Lewis R, Maynard L, Catto JWF, Cresswell J, Feber A, Griffiths TLR, Kelly JD, Knight A, Knowles M, McGrath J, Penegar S, Hall E, Mostafid H, on behalf of the CALIBER TMG. Recruitment aids for a phase II randomised trial in low risk bladder cancer. European Journal of Surgical Oncology , Volume 42 , Issue 11 , S244.

Lewis R, Maynard L, Catto JWF, Cresswell J, Feber A, Griffiths TLR, Kelly JD, Knight A, Knowles M, McGrath J, Penegar S, Hall E, Mostafid H, on behalf of the CALIBER TMG. Recruitment aids for a phase II randomised trial in low risk bladder cancer. Poster presentation at: NCRI Cancer Conference; 2016 November 6-9; Liverpool, UK.

Clinical trials

Division of Clinical Studies

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.