Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
ConditionUrinary Bladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gemcitabine and Cisplatin (DD GC)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov