A clinical Trial Comparing instillation of Single dose Gemcitabine versus Mitomycin-C in urinary bladder after Complete Resection of urinary bladder cancer
- Conditions
- Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027068
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
a) Age 18 or above
b) Lesion suspicious for Non-muscle invasive bladder cancer after complete TURBT
c) General condition of the patient sufficient for 1 yr or more of follow-up (according to the attending physician)
a) Any prior non-urothelial or muscle-invasive bladder cancer
b)History of any prior intravesical therapy for non muscle invasive bladder cancer in last
5 years
c) Intraoperative evidence of tumor in urethra or ureter
d)Suspicion of muscle invasion after complete resection
e)Previous pelvic radiotherapy for any malignancy.
f)Prior treatment for any malignancy within 5 years (other than nonâ??muscle-invasive
bladder urothelial cancer).
g)Significant renal dysfunction (S. Cr >2)
h)Hepatic dysfunction
i)Poor performance status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of a single dose immediate intravesical instillation of gemcitabine versus mitomycin post TURBT in preventing recurrence of completely resected non muscle invasive bladder cancer at one year.Timepoint: To determine the efficacy of a single dose immediate intravesical instillation of gemcitabine versus mitomycin post TURBT in preventing recurrence of completely resected non muscle invasive bladder cancer at one year.
- Secondary Outcome Measures
Name Time Method To compare the toxicities between the arms.Timepoint: 1 year;To test whether a single instillation of intravesical gemcitabine can improve the time to progression to muscle invasive disease compared to mitomycin in this patient population.Timepoint: 1 year