A phase 2 trial of GN (gemcitabine + nedaplatin) therapy for advanced urothelial cancer patients with pre-treatment of cisplatin or carboplatin.
Phase 2
- Conditions
- urothelial cancer
- Registration Number
- JPRN-UMIN000021298
- Lead Sponsor
- Yamagata University, Department of Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with sever bone marrow suppression 2) Patinets with interstitial pneumonitis or lung fibrosis 3) Patients with prior radiotherapy for chest 4) Patients with hypersensitivity reaction for the protocol drugs 5) Patients without histological diagnosis 6) Patients with prior therapy used nedaplatin 7) Patients without lesions assessed by RECISTv1.1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method adverse event, disease control rate, progression free survival, overall survival, quality of life