NCT07184021Not yet recruitingPhase 2
Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
Neoadjuvent Dose-dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer:Results of a Phase 2 Trial
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Sept 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Assiut University
- Diseases
- Bladder cancer
- NCT number
- NCT07184021
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From Sept 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic chemotherapy or radiotherapy for bladder cancer.
Other illness
- Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).
Lab values
- Significant renal impairm ent (creatinine clearance \< 60 mL/min).
Other
- Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%).
- Clinical or radiological evidence of distant metastases (M1).
- ECOG performance status ≥ 2.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut university Hospital-Departement of clinical oncology. Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.