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Brief Title: Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Official Title: CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer
Study ID: NCT02070120
Brief Summary: Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic. This multicentre study aims to establish the short term efficacy of chemoresection using chemotherapy within the bladder for the treatment of NMIBC. Should the levels of complete response following chemoresection meet predefined criteria, a larger phase III trial would be developed to assess longer term disease related endpoints, with the aim of standardising management of recurrent low risk NMIBC and potentially removing the need for over a thousand patients each year to undergo surgery.
Detailed Description: CALIBER is a two stage phase II, multicentre, randomised controlled trial (RCT). A control group has been included to provide prospective data about surgical management and outcomes and assess feasibility of recruitment to a randomised study. Stage 1: 80 patients will be recruited with treatment allocated 2:1 by randomisation between chemoresection and surgical management. Stage 2: If the stop/go activity criteria at the end of stage 1 indicate that recruitment should continue, 9 additional participants will be recruited, all of whom will receive chemoresection. Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg Mitomycin C (MMC) as outpatients. This treatment will be delivered via catheter under local anaesthetic. Patients assigned to the surgical management group will receive the standard surgical management in use at their hospital for treatment of recurrence which may include a single post-operative installation of 40mg MMC within 24 hours. All participants will be followed up at 3 weeks from the start of treatment (ie at time of final MMC instillation for chemoresection group) and each will receive a cystoscopy three months from the end of treatment to assess response, in accordance with European Association of Urology (EAU) guidelines. Subsequent cystoscopic follow up will take place 12 months after treatment if recurrence-free at 3 months and then annually.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Macclesfield District General Hospital, Macclesfield, Cheshire, United Kingdom
James Cook University Hospital, Middlesbrough, Cleveland, United Kingdom
West Cumberland Hospital, Whitehaven, Cumbria, United Kingdom
Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom
Derriford Hospital, Plymouth, Devon, United Kingdom
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Dorset County Hospital, Dorchester, Dorset, United Kingdom
Cumberland Infirmary, Carlisle, England, United Kingdom
Broomfield Hospital, Chelmsford, Essex, United Kingdom
Princess Alexandra Hospital, Harlow, Essex, United Kingdom
Cheltenham General Hospital, Cheltenham, Gloucestershire, United Kingdom
Gloucestershire Royal Hospital, Gloucester, Gloucestershire, United Kingdom
Royal Oldham Hospital, Manchester, Greater Manchester, United Kingdom
Basingstoke and North Hampshire Hospital, Basingstoke, Hampshire, United Kingdom
Southampton General Hospital, Southampton, Hampshire, United Kingdom
Hereford County Hospital, Hereford, Herefordshire, United Kingdom
Darent Valley Hospital, Dartford, Kent, United Kingdom
Medway Maritime Hospital, Gillingham, Kent, United Kingdom
Royal Preston Hospital, Preston, Lancashire, United Kingdom
Leicester General Hospital, Leicester, Leicestershire, United Kingdom
Northwick Park Hospital, Harrow, Middlesex, United Kingdom
Churchill Hospital, Headington, Oxfordshire, United Kingdom
Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom
Ipswich Hospital, Ipswich, Suffolk, United Kingdom
Croydon University Hospital, Croydon, Surrey, United Kingdom
Royal Surrey County Hospital, Guildford, Surrey, United Kingdom
Freeman Hospital, Newcastle upon Tyne, Tyne And Wear, United Kingdom
New Cross Hospital, Wolverhampton, West Midlands, United Kingdom
St Richard's Hospital, Chichester, West Sussex, United Kingdom
Worthing Hospital, Worthing, West Sussex, United Kingdom
Pinderfields General Hospital, Wakefield, West Yorkshire, United Kingdom
Kidderminster Hospital, Kidderminster, Worcestershire, United Kingdom
Alexandra Hospital, Redditch, Worcestershire, United Kingdom
Worcester Royal Hospital, Worcester, Worcestershire, United Kingdom
St James's University Hospital, Leeds, Yorkshire, United Kingdom
University College Hospital, London, , United Kingdom
Withington Hospital, Manchester, , United Kingdom
Wythenshawe Hospital, Manchester, , United Kingdom
Name: Hugh Mostafid
Affiliation: Royal Surrey County Hospital NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR