Multi-center, phase II study for combination therapy with weekly pacritaxel and 5'-DFUR in patients with unresectable or recurrent gastric cancer
Phase 2
- Conditions
- Advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000008631
- Lead Sponsor
- Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1) Drug hypersensitivity. 2) Infection and inflammation. 3) Prior infusion of paclitaxel 4) Peripheral neuropathy 5) Active synchronous malignancy. 6) Brain metastasis. 7) Severe mental disorders. 8) Symptomatic pulmonary fibrosis or interstitial pneumonia. 9) Severe systemic edema. 10) A large amount of pleural effusion or peritoneal fluid. 11) Severe heart disease. 12) Myocardial infarction within six months. 13) DM with insulin injection. 14) Pregnant patient
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect