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Bladder CancerPhase 2CALIBERNCT02070120

Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer

A Phase 2 study testing Mitomycin C and Surgical Management in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 38 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Mitomycin C and Surgical Management
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
38 sitesUnited Kingdom
Study dates
Oct 2014to Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written informed consent
  • 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
  • Histologically confirmed Transitional-cell carcinoma (TCC) at original diagnosis
  • Aged 16 or over
  • Satisfactory pre-treatment haematology values and serum creatinine < 1.5 x Upper Limit of Normal (ULN)
  • Negative pregnancy test for women of child-bearing potential

Who cannot join

  • 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
  • Any history of histologically confirmed non-TCC bladder cancer
  • Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
  • Any prior treatment of the trial entry recurrence (including biopsy)
  • Previous MMC chemotherapy other than a single instillation at diagnostic surgery
  • Known allergy to MMC
Show all 16Show fewer
  • 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)
  • Known or suspected reduced bladder capacity (<100ml)
  • Significant bleeding disorder
  • 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.
  • Active or intractable urinary tract infection
  • Urethral stricture or anything impeding the insertion of a catheter
  • Large narrow neck diverticula
  • Significant urinary incontinence
  • Any other conditions that in the Principal Investigator's opinion would contraindicate protocol treatment
  • Unable or unwilling to comply with study procedures or follow up schedule

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United Kingdom38 sites

  • Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA

  • Royal Bournemouth Hospital

    Bournemouth, Dorset, BH7 7DW

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Broomfield Hospital

    Chelmsford, Essex, CM1 5ET

  • Cheltenham General Hospital

    Cheltenham, Gloucestershire, GL53 7AN

  • St Richard's Hospital

    Chichester, West Sussex, PO19 6SE

  • Croydon University Hospital

    Croydon, Surrey, CR7 7YE

  • Darent Valley Hospital

    Dartford, Kent, DA2 8DA

  • Dorset County Hospital

    Dorchester, Dorset, DT1 2JY

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

  • Medway Maritime Hospital

    Gillingham, Kent, ME7 5NY

  • Gloucestershire Royal Hospital

    Gloucester, Gloucestershire, GL1 3NN

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • Princess Alexandra Hospital

    Harlow, Essex, CM20 1QX

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

  • Churchill Hospital

    Headington, Oxfordshire, OX3 7LE

  • Hereford County Hospital

    Hereford, Herefordshire, HR1 2ER

  • Ipswich Hospital

    Ipswich, Suffolk, IP4 5PD

  • Kidderminster Hospital

    Kidderminster, Worcestershire, DY11 6RJ

  • St James's University Hospital

    Leeds, Yorkshire, LS9 7TF

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

  • University College Hospital

    London, NW1 2BU

  • Macclesfield District General Hospital

    Macclesfield, Cheshire, SK10 3BL

  • Royal Oldham Hospital

    Manchester, Greater Manchester, OL1 2JH

  • Withington Hospital

    Manchester, M20 2LR

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • James Cook University Hospital

    Middlesbrough, Cleveland, TS4 3BW

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Derriford Hospital

    Plymouth, Devon, PL6 8DH

  • Royal Preston Hospital

    Preston, Lancashire, PR2 9HT

  • Alexandra Hospital

    Redditch, Worcestershire, B98 7UB

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Pinderfields General Hospital

    Wakefield, West Yorkshire, WF1 4DG

  • West Cumberland Hospital

    Whitehaven, Cumbria, CA28 8JG

  • New Cross Hospital

    Wolverhampton, West Midlands, WV10 0QP

  • Worcester Royal Hospital

    Worcester, Worcestershire, WR5 1DD

  • Worthing Hospital

    Worthing, West Sussex, BN11 2DH

Other trials in United Kingdom

About this study

Official title: CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer

Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic. This multicentre study aims to establish the short term efficacy of chemoresection using chemotherapy within the bladder for the treatment of NMIBC.

Should the levels of complete response following chemoresection meet predefined criteria, a larger phase III trial would be developed to assess longer term disease related endpoints, with the aim of standardising management of recurrent low risk NMIBC and potentially removing the need for over a thousand patients each year to undergo surgery.

Read the detailed description

CALIBER is a two stage phase II, multicentre, randomised controlled trial (RCT). A control group has been included to provide prospective data about surgical management and outcomes and assess feasibility of recruitment to a randomised study.

Stage 1: 80 patients will be recruited with treatment allocated 2:1 by randomisation between chemoresection and surgical management.

Stage 2: If the stop/go activity criteria at the end of stage 1 indicate that recruitment should continue, 9 additional participants will be recruited, all of whom will receive chemoresection.

Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg Mitomycin C (MMC) as outpatients. This treatment will be delivered via catheter under local anaesthetic.

Patients assigned to the surgical management group will receive the standard surgical management in use at their hospital for treatment of recurrence which may include a single post-operative installation of 40mg MMC within 24 hours.

All participants will be followed up at 3 weeks from the start of treatment (ie at time of final MMC instillation for chemoresection group) and each will receive a cystoscopy three months from the end of treatment to assess response, in accordance with European Association of Urology (EAU) guidelines.

Subsequent cystoscopic follow up will take place 12 months after treatment if recurrence-free at 3 months and then annually.

Conditions
Bladder Cancer
Being tested
Mitomycin C, Surgical Management
Keywords
Nonmuscle invasive bladder cancer (NMIBC), Mitomycin C, Chemoresection
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitomycin CDrug

    Also called MMC

    Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.

  • Surgical ManagementProcedure or surgery

    Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.

Study groups in NCT02070120
Study groupRoleWhat they receive
ChemoresectionExperimental4 once weekly outpatient intravesical instillations 40mg Mitomycin C
Receives: Drug: Mitomycin C
Surgical ManagementOtherSurgical management according to local practice
Receives: Procedure: Surgical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate with chemoresection

    Defined as an absence of any tumour following chemoresection and will be assessed visually at 3 month check cystoscopy by patients' urologists. A biopsy of the tumour bed would take place to confirm visual assessment of complete response.

    Measured: 3 months

Secondary outcomes (7)

  1. Treatment compliance in chemoresection group

    Patients who receive 4 MMC instillations with no more than 14 days between each instillation will be described as fully compliant.

    Measured: Duration of treatment (3 weeks)

  2. Salvage surgery rates

    Assessing trans-urethral resection and biopsy rates following initial treatment in both treatment groups

    Measured: 3 years

  3. Progression-free survival

    Defined as time from randomisation to the first of muscle invasive bladder recurrence, recurrence in the pelvic nodes, distant metastatic recurrence or death from any cause.

    Measured: 3 years

  4. Toxicity (NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4 and Clavien Dindo grade (in surgical group))

    Measuring side effects of both treatments using clinician reported toxicity scales

    Measured: up to 12 months

  5. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Superficial Bladder Cancer (BLS24) questionnaire

    Assessing side effects and impact of both treatments on patient reported quality of life.

    Measured: up to 12 months

  6. Health service utilisation

    Assessed using prospective data collection of health resource usage.

    Measured: up to 12 months

  7. Recurrence free interval

    Time from end of treatment to first relapse, in patients confirmed recurrence free at 3 months

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJan 2018
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02070120
Sponsor's protocol ID
ICR-CTSU/2013/10041
Other IDs
2013-005095-18
Acronym
CALIBER
Status last verified
Mar 2020
First submitted
19 Feb 2014
Last updated
19 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Mostafid AH, Porta N, Cresswell J, Griffiths TRL, Kelly JD, Penegar SR, Davenport K, McGrath JS, Campain N, Cooke P, Masood S, Knowles MA, Feber A, Knight A, Catto JWF, Lewis R, Hall E. CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer. BJU Int. 2020 Jun;125(6):817-826. doi: 10.1111/bju.15038. Epub 2020 Apr 3.

    PubMed 32124514

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitomycin C and Surgical Management in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 38 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate with chemoresection (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02070120, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.

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