Condition category
Cancer
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
12/10/2016
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

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

As of 12/10/2016:
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

Initial:
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

As of 12/10/2016:
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

Initial:
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

27/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research
Surrey Clinical Trials & Statistics Unit (ICR-CTSU) Section of Clinical Trials Brookes Lawley Building 15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/10/2016: Made amendments to participant inclusion and exclusion criteria and added secondary outcomes (timestamped in record). Added clinicaltrials.gov registration number to record 14/01/2016: Internal corrections.