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Spots Global Cancer Trial Database for Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer

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Trial Identification

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

Conditions

Bladder Cancer

Study Description

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.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Hugh Mostafid

Affiliation: Royal Surrey County Hospital NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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