Efficacy of palonosetron plus aprepitant in preventing chemoradiotherapy-induced nausea and emesis in patients receiving daily low-dose cisplatin-based concurrent chemoradiotherapy for uterine cervical cancer: a phase II study
Not Applicable
- Conditions
- cervical cancer
- Registration Number
- JPRN-UMIN000011616
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
i) severe systemic or uncontrolled disease (uncontrolled diabetes mellitus or hypertension) ii) asymptomatic metastases to the brain iii) seizure disorder requiring anticonvulsants unless clinically stable iv) uncontrolled pleural effusion or ascites v) gastric outlet or intestinal obstruction vi) a known hypersensitivity to palonosetron, granisetron, or other 5-HT3-receptor antagonists or dexamethasone ingredients. In the period between registration of patients and administration of the study drug, patients who met the following discontinuation criteria were withdrawn from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoints of this study were proportion of patients with complete response (defined as no emetic episodes and no rescue medication) during the overall phase.
- Secondary Outcome Measures
Name Time Method The secondary endpoints were complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea), the number of emetic episodes, severity of nausea, adverse effect, time to administration of rescue therapy, and total dose of rescue dexamethasone.