Status:
NOT_YET_RECRUITING
Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
Lead Sponsor:
Assiut University
Conditions:
Urinary Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dow...
Detailed Description
Muscle-invasive bladder cancer (MIBC) poses a significant therapeutic challenge due to its high risk of progression and metastasis. Radical cystectomy remains the cornerstone of curative treatment; ho...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07184021
Start Date
September 1 2025
End Date
September 1 2027
Last Update
September 19 2025
Active Locations (1)
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1
Assiut university Hospital-Departement of clinical oncology.
Asyut, Egypt