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Comparison of drug combination (gemcitabine and docetaxel) with BCG to determine better cancer survival and patient specific results for use after transurethral endoscopic surgery in non-invasive urinary bladder mass

Clinical Efficacy and Safety and QOL impact of Intravesical BCG versus Gemcitabine + Docetaxel in Adjuvant management of BCG-naive NMIBC - Clinical Efficacy, Safety and Quality-of-Life impact of Intravesical BCG versus Gemcitabine-Docetaxel in Adjuvant management of BCG-naive Non-Muscle Invasive Urinary Bladder Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084434
Enrollment
80
Registered
2025-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: N328- Other specified disorders of bladder

Interventions

Intervention1: Gemcitabine and Docetaxel: Dose - Gemcitabine 1000 mg + docetaxel 40 mg (fixed dose) in 50 ml normal saline Route - Intravesical (urinary bladder) instillation Frequency - once a week f

Sponsors

Aviral Srivastava
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 80 years. 2.ECOG performance status 0-2 3.Complete clearance achieved during TURBT 4.Post TURBT- intermediate and high-risk NMIBC (as per EAU risk group) 5.Patients of either gender 6.Willingness to participate in study

Exclusion criteria

Exclusion criteria: 1. Histopathological diagnosis of MIBC/ non cancer 2. Patients with concomitant upper tract urothelial cancer 3. Known hypersensitivity/prior systematic therapy-Gemcitabine, Docetaxel or BCG 4. Prior recipients of intravesical therapy for NMIBC within 6 months 5. Hepatic or Renal dysfunction/ Pregnancy 6. Active UTI/ GUTB 7. Patients who refuse to give consent 8. Variant histology (squamous cell carcinoma / adenocarcinoma / neuroendocrine carcinoma/ sarcomatoid, micropapillary, or plasmacytoid).

Design outcomes

Primary

MeasureTime frame
Recurrence free survival and progression free survivalTimepoint: 1 year—

Secondary

MeasureTime frame
adverse effects and cost-benefitTimepoint: 1 year—

Countries

India

Contacts

Public ContactAVIRAL SRIVASTAVA

Institute of Medical Sciences, Banaras Hindu University

drsameertrivedibhu@gmail.com7976257137

Outcome results

None listed

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