Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer
NCT ID: NCT02948543
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
501 participants
INTERVENTIONAL
2013-07-31
2024-12-31
Brief Summary
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Detailed Description
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Background:
Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell carcinoma (TCC) despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin (MM) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.
General Aim:
To determine the efficacy and safety of MM in addition to BCG in patients with NMIBC.
Design:
Open label, randomised, stratified, 2-arm multicentre phase 3 clinical trial. Population: The target population is adults with resected, high-risk NMIBC (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment. Key eligibility criteria include: prior transurethral resection of all visible tumour, adequate organ function, and ECOG performance status 0-2.
Study Treatments:
Arm A: Intravesical BCG Alone (standard): Induction (weekly x 6), followed by Maintenance (monthly x 10); or Arm B: Intravesical BCG + MM (experimental): Induction (weekly x 9), followed by Maintenance (monthly x 9).
Statistical Considerations:
A sample size of 500 (followed until 213 events are observed) provides 85% power to detect a 10% improvement in disease free survival (DFS) rate at 2 years from 70% on BCG alone to 80% on BCG and MM (hazard ratio 0.63) at a significance level of 0.05, allowing for 10% non-compliance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Bacillus of Calmette-Guerin (BCG)
A strain of tubercle bacillus which modifies biologic response.
Mitomycin (MM)
An antibiotic produced by a soil actinomycete which inhibits DNA synthesis.
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.
Bacillus of Calmette-Guerin (BCG)
A strain of tubercle bacillus which modifies biologic response.
Interventions
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Bacillus of Calmette-Guerin (BCG)
A strain of tubercle bacillus which modifies biologic response.
Mitomycin (MM)
An antibiotic produced by a soil actinomycete which inhibits DNA synthesis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Cancer Australia
OTHER
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Dickon Hayne
Role: STUDY_CHAIR
Fiona Stanley Hospital
Locations
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Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Southside Cancer Care Centre
Miranda, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
GenesisCare
St Leonards, New South Wales, Australia
The Tweed Hospital
Tweed Heads, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Footscray Hospital
Footscray, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Austin Health - Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital - City Campus
Parkville, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Nottingham City Hospital - City Campus
Nottingham, , United Kingdom
Countries
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Other Identifiers
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12613000513718
Identifier Type: REGISTRY
Identifier Source: secondary_id
ANZUP 1301
Identifier Type: -
Identifier Source: org_study_id
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