A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.
Phase 2
Recruiting
- Conditions
- urothelial cancer
- Registration Number
- JPRN-UMIN000010460
- Lead Sponsor
- Yokohama city university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1. Receiving pimozide (MVAC or GC therapy) 2. With other sever diseases 3. Clinical suspicion or history of metastasis to brain or meninges 4. Patients who need anticonvulsants therapy 5. Ascites and/or pleural effusion to need treatment 6. Pyloric stenosis and/or intestinal obstruction 7. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 8. History of drug allergy 9. Pregnant or lactating women or women of childbearing potential, and no birth-control 10. Patient who doesn't have ability or intention that cooperates for procedure of the study 11. Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method