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Clinical Trials in Egypt / NCT07184021
Starting soon Phase 2

Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer

NCT07184021 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Phase 2
Started
2025-09
Last updated
2025-09-19

Condition(s) studied

Urinary Bladder Cancer

Investigational drug(s) / intervention(s)

Gemcitabine and Cisplatin (DD GC) →

Gemcitabine and Cisplatin (DD GC): Participants will receive neoadjuvant ddGC, consisting of gemcitabine and cisplatin administered at shortened intervals (e.g., gemcitabine 1200 mg/m² on days 1 and 8, fractionated cisplatin 35 mg/m² on day 1and 8, every 14 days) with appropriate growth factor support. A total of four cycles are planned before radical cystectomy.

Study summary

To evaluate the feasibility, safety, and pathological response of dose-dense neoadjuvant gemcitabine and cisplatin in patients with muscle-invasive bladder cancer, with the goal of improving tumor downstaging and optimizing outcomes before radical cystectomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0. * Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min). * Candidate for radical cystectomy after neoadjuvant treatment. * ECOG performance status 0-1. * Adequate bone marrow, liver, and renal function as per institutional standards. Exclusion Criteria: Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%). * Clinical or radiological evidence of distant metastases (M1). * Prior systemic chemotherapy or radiotherapy for bladder cancer. * Significant renal impairm ent (creatinine clearance \< 60 mL/min). * ECOG performance status ≥ 2. * Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).

Primary outcome measure(s)

  • Pathologic Complete Response (pT0N0) Rate — At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).
    Proportion of participants with no residual invasive or non-invasive tumor in the bladder and no lymph node involvement (ypT0N0) at the time of radical cystectomy, as determined by histopathological examination of the surgical specimen.

Trial sites (1)

FacilityCityRegionStatus
Assiut university Hospital-Departement of clinical oncology. Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07184021 on ClinicalTrials.gov ↗ ← All trials in Egypt