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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Gemcitabine and Cisplatin (DD GC)
Drug
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Neoadjuvant Dose-Dense Gemcitabine and Cisplatin (DDGC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pathologic Complete Response (pT0N0) Rate

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.

Time frame

At the time of radical cystectomy (approximately 4-6 weeks after completion of neoadjuvant chemotherapy).

Sponsors and contacts

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Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: