FindTrial
Sign In

Comparison between Intravesical instillation of Chemotherapy And Immunotherapy in patients with Bladder Cancer

To determine the Efficacy and Safety of Intravesical Chemotherapy (Gemcitabine + Mitomycin C) compared with Immunotherapy (BCG) in Reducing Progression and Recurrence Among Patients with High Grade Non Muscle Invasive Bladder Cancer Post TURBT: A RCT - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/093985
Enrollment
74
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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 Chemotherapy: Injection Gemcitabine Injection MITOMYCIN C -instilled weekly for 8 weeks followed by once in 3 months but should not extend beyond 1 year Control Intervent

Sponsors

GSVM MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Confirmed Pathology Report of Ca-Bladder (Non Muscle Invasive Bladder Cancer) -Available for whole duration of study -Absence of Any Concomitant Upper tract Urothelial Cancer

Exclusion criteria

Exclusion criteria: -Presence of Lymphovascular Space Invasion or micropapillary disease -Patients receiving systemic therapy for Ca Bladder -Patient receiving current or prior External Beam RadioTherapy (EBRT) within 5 years -Pregnant or Lactating Females or refusing for contraception -Patients with symptomatic UTI or Cystitis -Patients with Metastatic bladder cancer -History of Malignancy of any other organ system within 5 years -Patient who cannot hold instillation for more than 1 hour (Overactive Bladder) -patient who cannot tolerate Intravesical dosing or surgical treatment Are hereby, excluded from the study

Design outcomes

Secondary

MeasureTime frame
To check for remission of Bladder tumour post commencement of intravesical therapyTimepoint: Radiological investigations (USG KUB) alongwith check Cystoscopy to be done every third month—

Primary

MeasureTime frame
Comparative study between Intravesical Chemotherapy and Immunotherapy in reducing Progression and Recurrence among patients with high grade Non Muscle Invasive Bladder CancerTimepoint: Subjects will be assessed every 3 months with check cystourethroscopy.—

Countries

India

Contacts

Public ContactShatakshi Mishra

Lala Lajpat Rai-Hallet Hospital, GSVM Medical College

vinaysinghkgmc99@gmail.com9660640989

Outcome results

None listed

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