Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Not Applicable
- Conditions
- cervical cancer, endometrial cancer, ovarian cancer
- Registration Number
- JPRN-UMIN000009215
- Lead Sponsor
- Sapporo medical university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
They had serious complication. No known CNS metastasis Patients who has a convulsive disorders that need anticonvulsants therapy They had ascites or pleural effusion needs paracentesis treatment Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus Patients with vomiting or nausea (>= Grade2) Hypersensitivity or severe drug allergy for 5-HT3RA Hypersensitivity or severe drug allergy for dexamethasone Pregnant, breastfeeding or expecting woman Patients with a history of palonosetron Without the capability or the intention of cooperating Participated in other anti-emetic clinical trial Patients judged inappropriate for this study by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy.
- Secondary Outcome Measures
Name Time Method (1) Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2)Complete control rate during acute phase (0-24hr) and delayed phase (24-120hr). (3) Adverse events defined on CTCAE ver 4.0