Urothelial carcinoma
Conditions
Interventions
A combination chemotherapy using Gemcitabine and Carboplatin
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1> Histologically or clinically confirmed urothelial carcinoma 2> Muscle invasive (T2 or more) or metastatic 3> Renal function of 30ml/min =< CCr =<60ml/min 4> Sufficient bone marrow, liver and cardiovascular function 5> Life expectancy of at least 3 months 6> 20-90 years old 7> written informed consent
Exclusion criteria
Exclusion criteria: 1. patients with severe bone marrow suppression 2. patients with allergy to any platinum agents including Carboplatin, or Gemcitabine 3. patients during Pregnancy or Lactation, and with the hope of pregnancy 4. patients with severe liver dysfunction 5. patients with severe / uncontrollable infection 6. patients with active Chicken pox infection 7. patients with interstitial pneumonia and pulmonary fibrosis 8 patients who underwent radiation therapy for lung 9. Patients who progressed during prior chemotherapy using Gemcitabine/Carboplatin or Gemcitabine/CDDP 10. Otherwise, patients who are judged to be not eligible by attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events / side effects including renal impairment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Response rate based on the RECIST criteria | — |
Countries
Japan
Contacts
Public ContactTohru Nakagawa
The University of Tokyo Hospital Department of Urology
Outcome results
None listed