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Comparative study of two adjuvant treatments Gemcitabine Docetaxel and BCG for Intermediate and HighRisk Non Muscle Invasive Bladder Cancer

Intravesical Gemcitabine Docetaxel vs Bacillus Calmette Guerin A comparative study of adjuvant treatment in Intermediate and High Risk Non Muscle Invasive Bladder Cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100721
Enrollment
300
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: C679- Malignant neoplasm of bladder, unspecified

Interventions

Intervention1: Intravesical sequential instillation of injection Gemcitabine and Docetaxel: Injection Gemcitabine 1g + Docetaxel 40mg sequential intravesical administration each drug to be retained f

Sponsors

GMC Jammu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histopathology reported non muscle invasive bladder cancer falling under category of intermediate and high risk NMIBC as per AUA Guidelines will be included in the study group. Patients will be included only after valid informed written consent for the study Adult patients above 18 yr and less than or equal to 80 years will be included. Both male and female patients will be included.

Exclusion criteria

Exclusion criteria: Patients not giving consent to be the part of study. Patients with muscle invasive bladder cancer. Pregnant and lactating females. Age less than 18 years or more than 80 years.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival at 24 monthsTimepoint: Base line assessment with Cystoscopy at initiation of therapy followed by Cystoscopy at 3rd month, 6th month 9th month, 12th month, 15th month, 18th month, and 24th month.

Secondary

MeasureTime frame
Adverse events & Patient-reported QoL scoresTimepoint: Patients will be assessed at the time of drug administration & on followup basis at 3rd month, 6th month, 9th month, 12th month, 15th month, 18th month, 21st month & 24th month.

Countries

India

Contacts

Public ContactVineet Bhardwaj

Superspeciality Hospital Government Medical College Jammu.

eliassharma@hotmail.com7006705101

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026