Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
NCT ID: NCT02070120
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
82 participants
INTERVENTIONAL
2014-10-31
2020-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemoresection
4 once weekly outpatient intravesical instillations 40mg Mitomycin C
Mitomycin C
Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.
Surgical Management
Surgical management according to local practice
Surgical Management
Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.
Interventions
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Mitomycin C
Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.
Surgical Management
Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of ≤6 using EORTC risk tables
* Histologically confirmed Transitional-cell carcinoma (TCC) at original diagnosis
* 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
* Any history of histologically confirmed non-TCC bladder cancer
* Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
* Any prior treatment of the trial entry recurrence (including biopsy)
* 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 had imaging of the upper urinary tract within 2 years prior to randomisation)
* Known or suspected reduced bladder capacity (\<100ml)
* Significant bleeding disorder
* Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.
* 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
* Unable or unwilling to comply with study procedures or follow up schedule
16 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Hugh Mostafid
Role: PRINCIPAL_INVESTIGATOR
Royal Surrey County Hospital NHS Foundation Trust
Locations
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Withington Hospital
Manchester, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Worcester Royal Hospital
Worcester, Worcestershire, United Kingdom
St James's University Hospital
Leeds, Yorkshire, United Kingdom
University College Hospital
London, , United Kingdom
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
Countries
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References
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Mostafid AH, Porta N, Cresswell J, Griffiths TRL, Kelly JD, Penegar SR, Davenport K, McGrath JS, Campain N, Cooke P, Masood S, Knowles MA, Feber A, Knight A, Catto JWF, Lewis R, Hall E. CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer. BJU Int. 2020 Jun;125(6):817-826. doi: 10.1111/bju.15038. Epub 2020 Apr 3.
Other Identifiers
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2013-005095-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICR-CTSU/2013/10041
Identifier Type: -
Identifier Source: org_study_id
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