Additional identifiers
EudraCT/CTIS number
2013-005095-18
IRAS number
ClinicalTrials.gov number
NCT02070120
Protocol/serial number
17640
Study information
Scientific title
A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
Acronym
CALIBER
Study hypothesis
Current hypothesis as of 10/04/2017:
To demonstrate that chemoresection has sufficient activity against NMIBC to warrant further investigation of its role as a potential alternative to surgical intervention for low risk NMIBC recurrence.
Previous hypothesis:
CALIBER aims to demonstrate that chemoresection will enable 60% of participants to avoid surgical intervention for low risk NMIBC recurrence, as assessed by response rate at 3 months.
Ethics approval(s)
NRES Committee South Central - Hampshire B, 29/08/2014, ref: 14/SC/1223
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Cancer; Subtopic: Bladder Cancer; Disease: Bladder (superficial)
Intervention
Chemoresection group: 4 once weekly instillations of 40mg MMC as outpatients
Surgical management group: Surgery according to local practice
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Mitomycin C
Primary outcome measure
Complete response to chemoresection 3 months post-treatment
Secondary outcome measures
Added 12/10/2016:
In the chemoresection group:
1. Treatment compliance
In both groups:
2. Time to recurrence in patients disease free at 3 months
3. Transurethral resection and biopsy rates
4. Progression-free survival
5. Toxicity
6. Quality of life
7. Health service utilisation
Overall study start date
01/11/2014
Overall study end date
30/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 29/03/2017:
1. Written informed consent
2. 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).
3. Histologically confirmed TCC at original diagnosis
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential
Previous inclusion criteria from 12/10/2016 to 29/03/2017:
1. Written informed consent
2. 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 ≤5 using EORTC risk tables).
3. Histologically confirmed TCC at original diagnosis
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential
Original inclusion criteria:
1. Written informed consent
2. 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)
3. Histologically confirmed TCC at original and any subsequent diagnoses
4. Aged 16 or over
5. Satisfactory pre-treatment haematology values Hb > 100 g/L and serum creatinine < 1.5xULN
6. Negative pregnancy test for women of child-bearing potential
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 174; UK Sample Size: 174
Total final enrolment
82
Participant exclusion criteria
Current exclusion criteria as of 29/03/2017:
1. 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
2. Any history of histologically confirmed non-TCC bladder cancer
3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
4. Any prior treatment of the trial entry recurrence (including biopsy)
5. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
6. Known allergy to MMC
7. 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)
8. Known or suspected reduced bladder capacity (<100ml)
9. Significant bleeding disorder
10. 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.
11. Active or intractable urinary tract infection
12. Urethral stricture or anything impeding the insertion of a catheter
13. Large narrow neck diverticula
14. Significant urinary incontinence
15. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
16. Unable or unwilling to comply with study procedures or follow up schedule
Previous exclusion criteria from 12/10/2016 to 29/03/2017:
1. 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
2. Any history of histologically confirmed non-TCC bladder cancer
3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
4. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
5. Known allergy to MMC
6. 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)
7. Known or suspected reduced bladder capacity (<100ml)
8. Significant bleeding disorder
9. 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
10. Active or intractable urinary tract infection
11. Urethral stricture or anything impeding the insertion of a catheter
12. Large narrow neck diverticula
13. Significant urinary incontinence
14. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
15. Unable or unwilling to comply with study procedures or follow up schedule
Original exclusion criteria:
1. 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)
2. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
3. Known allergy to MMC
4. 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)
5. Known or suspected reduced bladder capacity (<100ml)
6. Significant bleeding disorder
7. 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
8. Any other malignancy in the past 2 years (except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, DCIS/LCIS of the breast or prostate cancer in patients who have a life expectancy of >5 years upon trial entry)
9. Active or intractable urinary tract infection
10. Urethral stricture or anything impeding the insertion of a catheter
11. Large narrow neck diverticula
12. Significant urinary incontinence
13. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
14. Unable or unwilling to comply with study procedures or follow up schedule
Recruitment start date
28/01/2015
Recruitment end date
04/09/2017
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Study participating centre
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Study participating centre
Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
Study participating centre
West Cumberland Hospital
Homewood Rd
Whitehaven
CA28 8JG
United Kingdom
Study participating centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
M23 9LT
United Kingdom
Study participating centre
Withington Community Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom
Study participating centre
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study participating centre
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Study participating centre
Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Study participating centre
St James’s University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study participating centre
Croydon University Hospital
London Road
Thornton Heath
CR7 7YE
United Kingdom
Study participating centre
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study participating centre
Royal Oldham Hospital
Rochdale Road
Manchester
OL1 2JH
United Kingdom
Study participating centre
Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Study participating centre
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Study participating centre
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Study participating centre
New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom
Study participating centre
Darent Valley Hospital
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom
Study participating centre
Broomfield Hospital
Court Road
Chelmsford
CM1 7ET
United Kingdom
Study participating centre
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Study participating centre
Hereford County Hospital
Union Walk
Hereford
HR1 2ER
United Kingdom
Study participating centre
University College Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
Study participating centre
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Study participating centre
Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Study participating centre
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Study participating centre
St Richard’s Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
Study participating centre
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Study participating centre
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Study participating centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Study participating centre
Royal Preston Hospital
Sharoe Green Lane North
Preston
PR2 9HT
United Kingdom
Study participating centre
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Study participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study participating centre
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Study participating centre
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Study participating centre
Princess Alexandra Hospital
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research
Sponsor details
-
London
SW7 3RP
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The main trial results will be published in a peer-reviewed journal, on behalf of all collaborators. Publication of primary outcome is planned for 2018.
Intention to publish date
31/12/2019
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from caliber-icrctsu@icr.ac.uk.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | recruitment aids | 01/11/2016 | Yes | No | |
| Other publications | recruitment aids | 01/05/2017 | Yes | No | |
| Results article | results | 01/03/2018 | Yes | No | |
| Results article | results | 01/04/2018 | Yes | No | |
| Results article | 12-month results | 01/03/2019 | Yes | No | |
| Results article | results | 01/06/2020 | Yes | No | |
| Protocol file | version 6 | 20/06/2017 | 18/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |