Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
CALIBER
CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer
2 other identifiers
interventional
82
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Longer than P75 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 19, 2020
March 1, 2020
3.3 years
February 19, 2014
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate with chemoresection
Defined as an absence of any tumour following chemoresection and will be assessed visually at 3 month check cystoscopy by patients' urologists. A biopsy of the tumour bed would take place to confirm visual assessment of complete response.
3 months
Secondary Outcomes (7)
Treatment compliance in chemoresection group
Duration of treatment (3 weeks)
Salvage surgery rates
3 years
Progression-free survival
3 years
Toxicity (NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4 and Clavien Dindo grade (in surgical group))
up to 12 months
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Superficial Bladder Cancer (BLS24) questionnaire
up to 12 months
- +2 more secondary outcomes
Study Arms (2)
Chemoresection
EXPERIMENTAL4 once weekly outpatient intravesical instillations 40mg Mitomycin C
Surgical Management
OTHERSurgical management according to local practice
Interventions
Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.
Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.
Eligibility Criteria
You may qualify if:
- Written informed consent
- 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
You may not qualify if:
- Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Macclesfield District General Hospital
Macclesfield, Cheshire, SK10 3BL, United Kingdom
James Cook University Hospital
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
West Cumberland Hospital
Whitehaven, Cumbria, CA28 8JG, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Dorset County Hospital
Dorchester, Dorset, DT1 2JY, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Broomfield Hospital
Chelmsford, Essex, CM1 5ET, United Kingdom
Princess Alexandra Hospital
Harlow, Essex, CM20 1QX, United Kingdom
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Royal Oldham Hospital
Manchester, Greater Manchester, OL1 2JH, United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, Hampshire, RG24 9NA, United Kingdom
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Hereford County Hospital
Hereford, Herefordshire, HR1 2ER, United Kingdom
Darent Valley Hospital
Dartford, Kent, DA2 8DA, United Kingdom
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY, United Kingdom
Royal Preston Hospital
Preston, Lancashire, PR2 9HT, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Churchill Hospital
Headington, Oxfordshire, OX3 7LE, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Ipswich Hospital
Ipswich, Suffolk, IP4 5PD, United Kingdom
Croydon University Hospital
Croydon, Surrey, CR7 7YE, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
St Richard's Hospital
Chichester, West Sussex, PO19 6SE, United Kingdom
Worthing Hospital
Worthing, West Sussex, BN11 2DH, United Kingdom
Pinderfields General Hospital
Wakefield, West Yorkshire, WF1 4DG, United Kingdom
Kidderminster Hospital
Kidderminster, Worcestershire, DY11 6RJ, United Kingdom
Alexandra Hospital
Redditch, Worcestershire, B98 7UB, United Kingdom
Worcester Royal Hospital
Worcester, Worcestershire, WR5 1DD, United Kingdom
St James's University Hospital
Leeds, Yorkshire, LS9 7TF, United Kingdom
University College Hospital
London, NW1 2BU, United Kingdom
Withington Hospital
Manchester, M20 2LR, United Kingdom
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
Related Publications (1)
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.
PMID: 32124514RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugh Mostafid
Royal Surrey County Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 25, 2014
Study Start
October 1, 2014
Primary Completion
January 1, 2018
Study Completion
September 1, 2020
Last Updated
March 19, 2020
Record last verified: 2020-03