High grade non muscle invasive bladder cancer
Conditions
Interventions
Trade Name: Mitomycin-C
Product Name: Mitomycin-C
Pharmaceutical Form: Concentrate for intravesical solution
INN or Proposed INN: Mitomycin-C
Concentration unit: mg milligram(s)
Trade Name: BCG
Produ
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion 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 = 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 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether patients treated with a combination of BCG and MM have fewer recurrences and live longer than patients treated with BCG alone.;Secondary Objective: To compare: 1) Activity (clear cystoscopy at 3 months) 2) Time to recurrence 3) Time to progression (recurrence of higher grade or stage cancer) 4) Safety (adverse events) 5) Health-related quality of life (HRQL) 6) Overall survival time (death from any cause) 7) Feasibility (compliance with intravesical therapy) 8) Marginal resource use (e.g. number of GP visits, number of outpatient and emergency department visits, number of inpatient admissions and the number of days admitted) ;Primary end point(s): Disease free survival;Timepoint(s) of evaluation of this end point: Evaluation timepoints of thus end point would be at time of identification of recurrent bladder cancer, time of death (if occurs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Activity (clear cystoscopy at 3 months) 2) Time to recurrence 3) Time to progression (recurrence of higher grade or stage cancer) 4) Safety (adverse events) 5) Health-related quality of life (HRQL) 6) Overall survival time (death from any cause) 7) Feasibility (compliance with intravesical therapy) 8) Marginal resource use (e.g. number of GP visits, number of outpatient and emergency department visits, number of inpatient admissions and the number of days admitted) | — |
Countries
Australia, United Kingdom
Contacts
Public ContactJen Boston
Nottingham University Hospitals NHS Trust
Outcome results
None listed