ACTRN12613000513718
Active, Not Recruiting
Phase 3
In patients with high-risk, non–muscle-invasive bladder cancer, is adding mitomycin to BCG for adjuvant intravesical therapy as good as or better than BCG alone for disease free survival?
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- bladder cancer
- Sponsor
- niversity of Sydney
- Enrollment
- 501
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 greater than or equal to 18 yrs
- •3\. No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial 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\. Is willing to complete 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
- •1\. Contraindications or hypersensitivity to investigational products, BCG and MM
- •2\. Prior treatment with any other intravesical agent including BCG or MM (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 e.g. 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
Outcomes
Primary Outcomes
Not specified
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