Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: Cases: Instillation of 6 doses of neoadjuvant intravesical mitomycin c (40mg each dose) over 2 weeks followed by cystoscopy 4-6 weeks after in cases of non muscle invasive bladder cance
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18years to 80 years. 2. ECOG performance status 0-2 3. No known contraindication to the drug 4. Patients of either gender 5. Willingness to participate in study
Exclusion criteria
Exclusion criteria: 1. Known history of invasive tumour of the bladder (T1+) 2. Known history of CIS of the bladder 3. Previous BCG-treatment within the last 24 months 4. Previous Mitomycin C-treatment (except single-shot postoperative instillation) 5. Known allergy or intolerance to Mitomycin C 6. Solid tumour with suspicions of invasion 7. Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions). 8. Small bladder volume (less than 100 ml) or incontinence 9. Acute cystitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the decrease in the size of the tumour following neoadjuvant treatment with mitomycin C in patients with non muscle invasive bladder cancer (NMIBC). 2.To compare the recurrence rate of NMIBC in patients treated with neoadjuvant mitomycin C versus those receiving standard treatment protocols. 3.To compare the requirement for surgical intervention in both groups i.e incomplete response in intervention group and recurrence in both groups Timepoint: Decrease in size of the tumour/ Complete disappearance will be assessed 4-6 weeks after instillation of intravesical mitomycin c. Recurrence will be assessed over a follow up period of 1 year. Need for surgery will be assessed at 4-6 weeks after intravesical mitomycin c. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the pathological response of NMIBC to neoadjuvant mitomycin C, including changes in tumour grade. 2. To evaluate the role and efficacy of mitomycin C in different radiological stages (VIRADS) of NMIBC. 3. To assess the impact of neoadjuvant mitomycin C on the incidence and severity of intraoperative bleeding in patients with NMIBC. 4. To investigate the safety and tolerability of neoadjuvant MMC in NMIBC patients. Timepoint: 1 year follow up period | — |
Countries
India
Contacts
Public ContactNarayan Shubham
Institute of Medical Sciences, Banaras Hindu University
Outcome results
None listed