Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
- Conditions
- locally advanced head and neck cancer
- Registration Number
- JPRN-UMIN000025205
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
Exclusion criteria included fistulas, distant metastases, active bacterial or fungal infection; simultaneous or metachronous (within 5 years) second cancers except carcinoma in situ or intramucosal tumor (e.g., gastric or esophageal cancer curable by endoscopic mucosal resection); pregnancy or lactation; active gastrointestinal bleeding; pleural or pericardial effusion; massive ascites; history of severe heart disease, heart failure, myocardial infarction within 6 months, or angina pectoris attack within 6 months; cerebrovascular accident within 6 months; diabetes mellitus treated with insulin or poorly controlled; poorly controlled hypertension; chronic pancreatitis; positive HBs antigen; inability to refrain from smoking and drinking during treatment; and requirement for systemic steroids.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of 5-FU AUC SS between the initial and reduced dose of S-1 in the patients
- Secondary Outcome Measures
Name Time Method adverse event tumor reduction rate overall survival progression free survival time to treatment failure