A phase II randomised feasibility study of chemoresection or surgical manag... | Recruiting
A phase II randomised feasibility s... | Recruiting
A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
CALIBER

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Medical Conditions
  • Topic: Cancer
  • Subtopic: Bladder Cancer
  • Disease: Bladder (superficial)
Primary Contact Details
Mr Steven Penegar
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN24855462
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-chemotherapy-and-surgery-for-early-bladder-cancer-caliber
Research Details
  • 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.
Phase
Phase II
Study Design
Randomised; Interventional
Study Type
Interventional
Intervention

Chemoresection group: 4 once weekly instillations of 40mg MMC as outpatients
Surgical management group: Surgery according to local practice

Intervention Type
Drug
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 174; UK Sample Size: 174
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Plymouth Hospitals NHS Trust Derriford Road
Plymouth
PL6 8DH
Leeds Teaching Hospitals NHS Trust Dept of Haematology Level 3, Bexley Wing
Leeds
LS9 7TF
Southampton
SO16 6YD
Marton Rd
Middlesbrough
TS4 3BW
Barrack Road
Exeter
EX2 5DW
Windmill Road
Gillingham
ME7 5NY
Castle Lane East
Bournemouth
BH7 7DW
Newtown Road
Carlisle
CA2 7HY
Homewood Rd
Whitehaven
CA28 8JG
Southmoor Road
Wythenshawe
M23 9LT
Nell Lane
Manchester
M20 2LR
Egerton Road
Guildford
GU2 7XX
Aldermaston Road
Basingstoke
RG24 9NA
London Road
Thornton Heath
CR7 7YE
Freeman Road
Newcastle upon Tyne
NE7 7DN
Rochdale Road
Oldham
OL1 2JH
Heath Road
Ipswich
IP4 5PD
Gwendolen Road
Leicester
LE5 4PW
Wednesfield Road
Wolverhampton
WV10 0QP
Darenth Wood Road
Dartford
DA2 8DA
Court Road
Broomfield
CM1 7ET
Union Walk
Hereford
HR1 2ER
250 Euston Road
London
NW1 2PG
Aberford Road
Wakefield
WF1 4DG
Victoria Road
Macclesfield
SK10 3BL
Williams Avenue
Dorchester
DT1 2JY
Spitalfield Lane
Chichester
PO19 6SE
Lyndhurst Road
Worthing
BN11 2DH
Charles Hastings Way
Worcester
WR5 1DD
Glossop Road
Sheffield
S10 2JF
Sharoe Green Lane North
Fulwood
PR2 9HT
Sandford Road
Cheltenham
GL53 7AN
Watford Road
Harrow
HA1 3UJ
Hamstel Road
Harlow
CM20 1QX
Trial Contact(s)
Primary Trial Contact
Mr Steven Penegar
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A phase II randomised feasibility study of chemoresection or surgical management in low risk non muscle invasive bladder cancer
EudraCT Number
2013-005095-18
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
17640
Sponsor(s)
The Institute of Cancer Research
Key Dates

Recruitment Start Date

28 Jan 2015

Recruitment End Date

31 Dec 2017

Trial Start Date

01 Nov 2014

Trial End Date

28 Feb 2018

Date added to source

15 Jan 2015

Date updated in source

10 Apr 2017