A clinical Trial Comparing instillation of Single dose Gemcitabine versus Mitomycin-C in urinary bladder after Complete Resection of urinary bladder cancer

Phase 2

Not yet recruiting

• Conditions: Bladder disorders in diseases classified elsewhere,

• Registration Number: CTRI/2020/08/027068
• Lead Sponsor: AIIMS

Brief Summary

Bladdercancer (BC) is one of the most common urological malignancy. In about 75%,thedisease is confined to the mucosa and lamina propria and denoted as non-muscleinvasivebladder cancer (NMIBC). The current international guidelines recommenda single instillation of intravesical

MitomycinC (MMC) in the immediate postoperative period following complete transurethralresection of the bladder tumour (TURBT). This is primarily aimed at reducingthe tumour cells implantation and prevent the recurrence. Gemcitabine has beenrecently explored as single instillation intravesical chemotherapy in theimmediate postoperative period following TURBT. In the only

randomizedstudy, SWOG s0337 has shown that the single instillation intravesicalgemcitabine had significantly lower 4-year estimate recurrence rate as comparedto the saline irrigation for low risk tumours. Based on this study, the recentNCCN guidelines on BC, recommends gemcitabine as preferred chemotherapeuticagent for immediate intravesical therapy for low risk tumours. Till dateno  randomized trial is availablecomparing the intravesical gemcitabine with intravesical MMC which is thecurrent standard of practice. With this background, we designed this randomizedstudy comparing the single immediate instillationof intravesical gemcitabine with intravesical MMC following complete TURBT inpatients with NMIBC in terms of safety, efficacy and tolerance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-08
• Study Start: 2020-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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).

Exclusion Criteria

• 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 non–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.	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.	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.	1 year

Trial Locations

Locations (1)

AIIMS, New Delhi; 🇮🇳 South, DELHI, India

AIIMS, New Delhi

🇮🇳South, DELHI, India

Brusabhanu Naik

Principal investigator

9868449607

brusabhanu@gmail.com