Role of pre procedure mitomycin C inside the bladder in treatment in patients with recurrent Non invasive bladder cancer
- Conditions
- Health Condition 1: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2024/05/067430
- Lead Sponsor
- AIIMS bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All patients with recurrent NMIBC
1) Non-UC of the bladder
2) T2 and above tumours
3) Suspicion or presence of CIS
4) Pregnancy
5) Urinary incontinence
6) MIBC or benign disease
7) Variant histology
8) Prior intravesical MMC instillation for NMIBC within 3 y (intravesical MMC instillation within 3 y prior to study entry)
9)Prior hypersensitivity reaction history to MMC
10) Prior BCG treatment within the past 24 months
11) Neurogenic bladder
12) Untreated urinary tract infection
13) Prior systemic chemotherapy for any malignancy within 6 months
14) Any factors that would preclude study participation.
15) Withdrawal of consent at any time during the clinical trial
• No outpatient follow-up examination within 3 mo-1 y after TURBT
• Failed intravesical MMC instillation before TURBT even once due to some reasons
• Not eligible single intravesical chemotherapy instillation immediately after TURBT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of neoadjuvant MMC treatment in reducing the recurrence rate of BC calculated as the proportion of patients who achieve a complete response (no evidence of BC after 3, 6, 12 and 24 months).Timepoint: 3 months <br/ ><br>6 months <br/ ><br>12 months <br/ ><br>24 months
- Secondary Outcome Measures
Name Time Method to analyse the stage progression to MIBC in case of recurrence. <br/ ><br>•To look for the grade of progressTimepoint: 2 weeks <br/ ><br>3 weeks <br/ ><br>4 weeks