Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: Neoadjuvant Single-Dose Intravesical Gemcitabine Instillation in Patients of Non Muscle invasive bladder cancer undergoing Transurethral resection: Patients meeting the inclusion criter
Sponsors
Dr Muhammed Huzaifa
Eligibility
Inclusion criteria
Inclusion criteria: All consented preoperative cases of bladder tumor detected on ultrasound, CT or MR imaging.
Exclusion criteria
Exclusion criteria: Out of all patients fulfilling the inclusion criteria the following will be excluded a. Patients who do not give consent b. Patients who are unfit for surgery c. Suspected benign or muscle invasive bladder cancer (MIBC) on imaging d. Recurrent bladder tumor e. Large unresectable NMIBC f. Patient who have received prior intravesical therapy g. Patient with absolute neutrophil count below 1,500/mm , and platelet count less than 100,000/mm h. Prior hypersensitivity reaction history to Gemcitabine i. Neurogenic bladder j. Untreated urinary tract infection (UTI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the recurrence rate of bladder tumor at 6 months following TURBTTimepoint: To determine the recurrence rate of bladder tumor at 6 months following TURBT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine recurrence rate of bladder tumor at 2, 12months following TURBT 2. To assess the tolerability of intravesical gemcitabine by Common Terminology Criteria for Adverse events (CTCAE) version 4.0 3. Assessment of Tissue Penetration of Gemcitabine in TURBT Specimens Timepoint: Recurrence at 2 and 12 months | — |
Countries
India
Contacts
Public ContactDr Swarnendu Mandal
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed