Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Phase 1
Recruiting
- Conditions
- iver resection for liver metastasis of colorectal cancer
- Registration Number
- JPRN-UMIN000021146
- Lead Sponsor
- Oita university, faculty of medicine, department gastroenterology and pediatric surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1.Active synchronous or metachronous malignancy other than carcinoma in situ 2.Serious postoperative complications 3.Serious coexisting illness A) Uncontrolled diabetes mellitus B) Uncontrolled hypertension C) History of myocardial infarction, unstable angina within 6 months prior to the registration D) Severe pulmonary dysfunction E) Liver cirrhosis 4.Ascites or pleural effusion needed to 5.Positive HBs antigen 6.Bleeding, paralysis, obstruction or ulcer of gastrointestinal tract 7.Pregnant or nursing 8.Severe mental disorders 9.Not suitable for participating in the study for any other Reason by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Optimal dose
- Secondary Outcome Measures
Name Time Method Adverse event, Overall survival, Disease free survival, Pharmacokinetics