Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Nonmuscle invasive bladder cancer (NMIBC), Mitomycin C, Chemoresection
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Mitomycin C Type: Drug
Name: Surgical Management Type: Procedure
Overall Status
Not yet recruiting
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 phase II, multicentre, randomised clinical trial. CALIBER will aim to recruit 174 participants; randomised 2:1 with 116 patients in the chemoresection group and 58 patients in the surgical management (control) group.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: Inclusion Criteria:

- Written informed consent

- NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 NMIBC with a risk of recurrence score of ≤5 using EORTC risk tables

- Histologically confirmed Transitional-cell carcinoma (TCC) at original and any subsequent diagnoses

- Aged 16 or over

- Satisfactory pre-treatment haematology values and serum creatinine < 1.5 x Upper Limit of Normal (ULN)

- Negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

- Risk of recurrence score >5 at original or any subsequent diagnoses (including any history of: grade 3 or T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year)

- Previous MMC chemotherapy other than a single instillation at diagnostic surgery

- Known allergy to MMC

- Carcinoma involving the prostatic urethra or upper urinary tract (participants should have received an ultrasound of the upper urinary tract within 2 years prior to randomisation)

- Known or suspected reduced bladder capacity (<100ml)

- Significant bleeding disorder

- Lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active)

- Any other malignancy in the past 2 years (except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) / lobular carcinoma in situ (LCIS) of the breast or prostate cancer in patients who have a life expectancy of >5 years upon trial entry)

- Active or intractable urinary tract infection

- Urethral stricture or anything impeding the insertion of a catheter

- Large narrow neck diverticula

- Significant urinary incontinence

- Any other conditions that in the Principal Investigator's opinion would contraindicate protocol treatment
Locations
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
Status:
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom
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James Cook University Hospital
Middlesbrough, Cleveland, United Kingdom
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Royal Derby Hospital
Derby, Derbyshire, United Kingdom
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Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
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Dorset County Hospital
Dorchester, Dorset, United Kingdom
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Cumberland Infirmary
Carlisle, England, United Kingdom
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Broomfield Hospital
Chelmsford, Essex, United Kingdom
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Cheltenham General Hospital
Cheltenham, Gloucestershire, United Kingdom
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Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom
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Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, United Kingdom
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Darent Valley Hospital
Dartford, Kent, United Kingdom
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Medway Maritime Hospital
Gillingham, Kent, United Kingdom
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Leicester General Hospital
Leicester, Leicestershire, United Kingdom
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Harrogate District Hospital
Harrogate, North Yorkshire, United Kingdom
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King's Mills Hospital
Sutton-in-Ashfield, Nottinghamshire, United Kingdom
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Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
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Ipswich Hospital
Ipswich, Suffolk, United Kingdom
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Ashford and St Peter's Hospitals
Chertsey, Surrey, United Kingdom
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Frimley Park Hospital
Frimley, Surrey, United Kingdom
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Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Status:
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, United Kingdom
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University Hospital Coventry
Coventry, Warwickshire, United Kingdom
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New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
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St Richard's Hospital
Chichester, West Sussex, United Kingdom
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Worthing Hospital
Worthing, West Sussex, United Kingdom
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Pinderfields General Hospital
Wakefield, West Yorkshire, United Kingdom
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Worcester Royal Hospital
Worcester, Worcestershire, United Kingdom
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York District Hospital
York, Yorkshire, United Kingdom
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Hereford County Hospital
Hereford, United Kingdom
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Charing Cross Hospital
London, United Kingdom
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University College Hospital
London, United Kingdom
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Withington Hospital
Manchester, United Kingdom
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Wythenshawe Hospital
Manchester, United Kingdom
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Start Date
October 2014
Completion Date
July 2017
Sponsors
Institute of Cancer Research, United Kingdom
Source
Institute of Cancer Research, United Kingdom
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page