Condition category
Cancer
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
10/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Steven Penegar

ORCID ID

Contact details

Clinical Trials & Statistics Unit at the Institute of Cancer Research (ICR-CTSU)
The Institute of Cancer Research
London
SM2 5NG
United Kingdom

Additional identifiers

EudraCT number

2013-005095-18

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

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

Trial setting

Hospitals

Trial 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

Phase

Phase II

Drug names

Mitomycin C

Primary outcome measures

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 trial start date

01/11/2014

Overall trial end date

28/02/2018

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 174; UK Sample Size: 174

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

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medway Maritime Hospital
Windmill Road
Gillingham
ME7 5NY

Trial participating centre

Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW

Trial participating centre

Cumberland Infirmary
Newtown Road
Carlisle
CA2 7HY

Trial participating centre

West Cumberland Hospital
Homewood Rd
Whitehaven
CA28 8JG

Trial participating centre

Wythenshawe Hospital
Southmoor Road
Wythenshawe
M23 9LT

Trial participating centre

Withington Community Hospital
Nell Lane
Manchester
M20 2LR

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX

Trial participating centre

Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA

Trial participating centre

St James’s University Hospital
Beckett Street
Leeds
LS9 7TF

Trial participating centre

Croydon University Hospital
London Road
Thornton Heath
CR7 7YE

Trial participating centre

Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN

Trial participating centre

Royal Oldham Hospital
Rochdale Road
Manchester
OL1 2JH

Trial participating centre

Basingstoke & North Hampshire Hospital
Aldermaston Road
Basingstoke
RG24 9NA

Trial participating centre

Ipswich Hospital
Heath Road
Ipswich
IP4 5PD

Trial participating centre

Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW

Trial participating centre

New Cross Hospital
Wednesfield Road
Wolverhampton
WV10 0QP

Trial participating centre

Darent Valley Hospital
Darenth Wood Road
Dartford
DA2 8DA

Trial participating centre

Broomfield Hospital
Court Road
Chelmsford
CM1 7ET

Trial participating centre

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW

Trial participating centre

Hereford County Hospital
Union Walk
Hereford
HR1 2ER

Trial participating centre

University College Hospital
250 Euston Road
London
NW1 2PG

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL

Trial participating centre

Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY

Trial participating centre

St Richard’s Hospital
Spitalfield Lane
Chichester
PO19 6SE

Trial participating centre

Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH

Trial participating centre

Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD

Trial participating centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane North
Preston
PR2 9HT

Trial participating centre

Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH

Trial participating centre

Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ

Trial participating centre

Princess Alexandra Hospital
Hamstel Road
Harlow
CM20 1QX

Sponsor information

Organisation

The Institute of Cancer Research

Sponsor details

-
London
SW7 3RP
United Kingdom

Sponsor type

University/education

Website

http://www.icr.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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 quarter 4 2017.

Intention to publish date

01/10/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.