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

A Randomized Phase II Trial Comparing perioperative Single dose Intravesical Gemcitabine versus Mitomycin-C Following Complete Resection of Non Muscle Invasive Bladder Cancer: Evaluation of Efficacy and Tolerance

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027068

Enrollment

100

Registered

2020-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N33- Bladder disorders in diseases classified elsewhere

Interventions

Intervention1: Intravesical single dose Gemcitabine: Post TURBT instillation (2000 mg) Control Intervention1: Intravesical single dose Mitomycin C: Post TURBT instillation (40 mg)

Eligibility

Inclusion criteria

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

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 nonâ??muscle-invasive bladder urothelial cancer). g)Significant renal dysfunction (S. Cr >2) h)Hepatic dysfunction i)Poor performance status

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactBrusabhanu Nayak

AIIMS, New Delhi

brusabhanu@gmail.com9868449607

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026