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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02948543
Registration number
NCT02948543
Ethics application status
Date submitted
1/08/2016
Date registered
28/10/2016
Date last updated
18/06/2023
Titles & IDs
Public title
Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer
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Scientific title
Adding Mitomycin to Bacillus of Calmette-Guerin (BCG) as Adjuvant Intravesical Therapy for High-risk, Non-Muscle-invasive Bladder Cancer: a Randomised Phase 3 Trial
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Secondary ID [1]
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12613000513718
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Secondary ID [2]
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ANZUP 1301
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Universal Trial Number (UTN)
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Trial acronym
BCG+MM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Bacillus of Calmette-Guerin (BCG)
Treatment: Drugs - Mitomycin (MM)
Experimental: Treatment (Arm B):Intravesical BCG + MM - Induction (weekly x 9); and followed by Maintenance (monthly x 9) beginning 3 months after randomisation.
Dosage of Bacillus of Calmette-Guerin (BCG) dependent on preferred brand of BCG by participating institution. Either 2-8 x 10^8 CFU for OncoTICE or, 81mg for ImmuCYST and TheraCys. Prior to treatment commencement, investigators should nominate which BCG brand will be used. The same brand of BCG must be used for all treatment administered to an individual participant throughout the study.
Dosage of Mitomycin (MM) fixed at 40mg per instillation.
Other: Treatment (Arm A): Intravesical BCG - Induction (weekly x 6); and followed by Maintenance (monthly x 10) beginning 3 months after randomisation.
Dosage of Bacillus of Calmette-Guerin (BCG) dependent on preferred brand of BCG by participating institution. Either 2-8 x 10^8 CFU for OncoTICE or, 81mg for ImmuCYST and TheraCys. Prior to treatment commencement, investigators should nominate which BCG brand will be used. The same brand of BCG must be used for all treatment administered to an individual participant throughout the study.
Other interventions: Bacillus of Calmette-Guerin (BCG)
A strain of tubercle bacillus which modifies biologic response.
Treatment: Drugs: Mitomycin (MM)
An antibiotic produced by a soil actinomycete which inhibits DNA synthesis.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease free survival (death or recurrence)
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Assessment method [1]
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Measured from the date of randomisation until the date of disease recurrence, upper tract disease is first evident, or the date of death, or until the date last known to be alive and without disease recurrence. Assessed via cystoscopy.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Activity (Clear cystoscopy at 3 months)
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Assessment method [1]
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Treatment activity is defined as a negative cystoscopy & biopsy at nominal week 12 (i.e. after induction therapy, but prior to the commencement of maintenance therapy). Assessed via cystoscopy and biopsy.
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Timepoint [1]
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At 3 months after patient randomised
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Secondary outcome [2]
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Time to recurrence (recurrence)
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Assessment method [2]
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Measured from the date of randomisation until the first date recurrence is detected. Disease recurrence is defined as evidence on cystoscopy or biopsy of Ta or T1-4 disease, or if there is evidence of metastatic disease. Assessed via cystoscopy.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Time to progression (disease progression)
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Assessment method [3]
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Measured from the date of randomisation until the first date progression is detected. Disease progression is defined as evidence of disease that is of a higher grade or a higher stage than at baseline. Assessed via cystoscopy.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Safety (Adverse events graded according to CTC AE V4.0)
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Assessment method [4]
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The NCI Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4.03) will be used to classify and grade the intensity of adverse events after each treatment cycle.
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Timepoint [4]
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Measured before day 1 of each instillation during treatment.
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Secondary outcome [5]
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Health-Related Quality of Life
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Assessment method [5]
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Health related quality life is a composite outcome aggregated to arrive at one reported value to ensure multiple aspects of the participants life are adequately assessed and measured. The following questionnaires will be used; the 24-item EORTC Bladder Symptoms Quality of Life module (QLM-BLS24); the EORTC Core Quality of Life Questionnaire (QLQ-C30); and the International Prostate Symptom Score (I-PSS).
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Timepoint [5]
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Up to 5 years from the date of randomisation
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Secondary outcome [6]
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Overall survival time (death from any cause)
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Assessment method [6]
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Overall survival is defined as the interval from the date of randomisation to the date of death from any cause or the date last known to be alive.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Treatment Completion
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Assessment method [7]
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Treatment completion is defined as having received 75% or more of the planned numbers of induction and maintenance doses.
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Timepoint [7]
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Measured at end of study treatment (12 months after patient randomized).
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Secondary outcome [8]
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Marginal resource use
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Assessment method [8]
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Assessed via a specifically designed resource utilisation form (collecting information such as number, type and duration of visits).
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Timepoint [8]
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5 years after last patient randomized (or date last patient has died, whichever sooner).
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Eligibility
Key inclusion criteria
1. Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle
invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in
situ is allowed).
2. Age >= 18 yrs
3. No macroscopically visible disease at cystoscopy within 8 weeks prior to
randomisation. This may be either the initial Transurethral Resection of the Bladder
Tumour (TURBT) at which the primary tumour was completely resected, or a planned
second cystoscopy and/or re-resection done within 8 weeks of the initial TURBT.
4. ECOG Performance Status of 0-2
5. Adequate bone marrow, renal and liver function confirmed by pre-randomisation blood
tests.
6. Study treatment both planned and able to start within 4 weeks of randomisation
7. Has completed the HRQL questionnaires or is unable to complete them because of
literacy, insufficient English or limited vision
8. Willing and able to comply with all study requirements, including treatment, timing
and/or nature of all required assessments
9. Signed, written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contraindications or hypersensitivity to investigational products, BCG and Mitomycin
2. Prior treatment with any other intravesical agent including BCG or Mitomycin (excludes
single doses given post TURBT)
3. Current or past transitional cell carcinoma (TCC) of the upper urinary tract
4. Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
5. Bladder dysfunction precluding intravesical therapy eg. Severe urinary incontinence or
overactive or spastic bladder
6. Life expectancy < 3 months
7. Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g.
acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive
therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)
8. Prior radiotherapy of the pelvis
9. Prior or current treatment with radiotherapy-response or biological-response modifiers
10. Clinical evidence of existing active tuberculosis
11. History of another malignancy within 5 years prior to registration. Patients with
non-melanomatous carcinoma of the skin are eligible for this study.
12. Serious medical or psychiatric conditions that might limit the ability of the patient
to comply with the protocol.
13. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal,
infertile, or use a reliable means of contraception. Women of childbearing potential
must have a negative pregnancy test done within 7 days prior to registration. Men must
have been surgically sterilised or use a (double if required) barrier method of
contraception.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
501
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Nepean Hospital - Kingswood
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Recruitment hospital [3]
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Southside Cancer Care Centre - Miranda
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Recruitment hospital [4]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [5]
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GenesisCare - St Leonards
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Recruitment hospital [6]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [7]
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Sydney Adventist Hospital - Wahroonga
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Recruitment hospital [8]
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Westmead Hospital - Westmead
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Recruitment hospital [9]
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Redcliffe Hospital - Redcliffe
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Recruitment hospital [10]
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Footscray Hospital - Footscray
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Recruitment hospital [11]
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Frankston Hospital - Frankston
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Recruitment hospital [12]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [13]
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The Alfred Hospital - Melbourne
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Recruitment hospital [14]
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Royal Melbourne Hospital - City Campus - Parkville
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Recruitment hospital [15]
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Epworth Healthcare - Richmond
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Recruitment hospital [16]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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2228 - Miranda
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Recruitment postcode(s) [4]
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2305 - New Lambton Heights
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Recruitment postcode(s) [5]
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2065 - St Leonards
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Recruitment postcode(s) [6]
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2485 - Tweed Heads
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Recruitment postcode(s) [7]
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2076 - Wahroonga
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Recruitment postcode(s) [8]
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2145 - Westmead
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Recruitment postcode(s) [9]
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4020 - Redcliffe
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Recruitment postcode(s) [10]
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3011 - Footscray
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Recruitment postcode(s) [11]
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3199 - Frankston
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Recruitment postcode(s) [12]
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3084 - Heidelberg
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Recruitment postcode(s) [13]
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3004 - Melbourne
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Recruitment postcode(s) [14]
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3050 - Parkville
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Recruitment postcode(s) [15]
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3121 - Richmond
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Recruitment postcode(s) [16]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Cancer Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Open label, randomised phase 3 trial of the addition of Mitomycin to BCG as adjuvant
intravesical therapy for high-risk, non-muscle-invasive bladder cancer. The study aim is to
compare disease-free survival between treatment arms: BCG alone versus Mitomycin in addition
to BCG.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02948543
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dickon Hayne
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Address
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Fiona Stanley Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02948543
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