A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
| ISRCTN | ISRCTN24855462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24855462 |
| EudraCT/CTIS number | 2013-005095-18 |
| ClinicalTrials.gov number | NCT02070120 |
| Secondary identifying numbers | 17640 |
- Submission date
- 14/01/2015
- Registration date
- 15/01/2015
- Last edited
- 18/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Mr Steven Penegar
Scientific
Scientific
Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
The Institute of Cancer Research
London
SM2 5NG
United Kingdom
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer |
| Study 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 |
| 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 |
Eligibility
| 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 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 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 centres
Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Gillingham
ME7 5NY
United Kingdom
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY
United Kingdom
Carlisle
CA2 7HY
United Kingdom
West Cumberland Hospital
Homewood Rd
Whitehaven
CA28 8JG
United Kingdom
Whitehaven
CA28 8JG
United Kingdom
Wythenshawe Hospital
Southmoor Road
Wythenshawe
M23 9LT
United Kingdom
Wythenshawe
M23 9LT
United Kingdom
Withington Community Hospital
Nell Lane
Manchester
M20 2LR
United Kingdom
Manchester
M20 2LR
United Kingdom
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
Exeter
EX2 5DW
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
St James’s University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Leeds
LS9 7TF
United Kingdom
Croydon University Hospital
London Road
Thornton Heath
CR7 7YE
United Kingdom
Thornton Heath
CR7 7YE
United Kingdom
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom
Newcastle upon Tyne
NE7 7DN
United Kingdom
Royal Oldham Hospital
Rochdale Road
Manchester
OL1 2JH
United Kingdom
Manchester
OL1 2JH
United Kingdom
Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Ipswich Hospital
Heath Road
Ipswich
IP4 5PD
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Leicester
LE5 4PW
United Kingdom
New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Darent Valley Hospital
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom
Dartford
DA2 8DA
United Kingdom
Broomfield Hospital
Court Road
Chelmsford
CM1 7ET
United Kingdom
Chelmsford
CM1 7ET
United Kingdom
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Hereford County Hospital
Union Walk
Hereford
HR1 2ER
United Kingdom
Hereford
HR1 2ER
United Kingdom
University College Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
London
NW1 2PG
United Kingdom
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Macclesfield
SK10 3BL
United Kingdom
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Dorchester
DT1 2JY
United Kingdom
St Richard’s Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom
Chichester
PO19 6SE
United Kingdom
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Worthing
BN11 2DH
United Kingdom
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Worcester
WR5 1DD
United Kingdom
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Sheffield
S10 2JF
United Kingdom
Royal Preston Hospital
Sharoe Green Lane North
Preston
PR2 9HT
United Kingdom
Preston
PR2 9HT
United Kingdom
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Princess Alexandra Hospital
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Harlow
CM20 1QX
United Kingdom
Sponsor information
The Institute of Cancer Research
University/education
University/education
-
London
SW7 3RP
England
United Kingdom
| Website | http://www.icr.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| 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. |
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 |
Additional files
Editorial Notes
18/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
30/03/2020: Publication references added.
18/09/2019: IPD sharing statement added.
10/09/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/09/2018 to 30/09/2019.
2. The intention to publish date was changed from 30/09/2018 to 31/12/2019.
26/03/2019: The total final enrollment has been added.
17/01/2018: The following changes were made:
1. Recruitment end date was changed from 31/12/2017 to 04/09/2017.
2. Overall trial end date was changed from 28/02/2018 to 30/09/2018.
3. intention to publish date was changed from 01/10/2017 to 30/09/2018.
10/04/2017: The public title was changed from "Chemoresection or surgical management in low risk non muscle invasive bladder cancer" to "A phase II randomised feasibility study of chemoresection and surgical management in low risk non muscle invasive bladder cancer"
29/03/2017: The recruitment end date was changed from 27/04/2017 to 31/12/2017.
