Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.
Phase 2
- Conditions
- Patients with gemcitabine-refractry advanced pancreatic cancer.
- Registration Number
- JPRN-UMIN000002154
- Lead Sponsor
- Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology Pancreatic cancer study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings. 2) Severe infection. 3) Severe complication. (heart failure, angina pectoris, arrhythmia, diabetes , intestines paralysis, ileus, myocardial infarction within 6 months after the onset.) 4) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy. 5) Watery diarrhea. 6) Jaundice. 7) Uncontrolled pleural or abdominal effusion. 8) Severe drug hypersensitivity. 9) History of other active malignancy. 10) Severe mental illness 11) Patients who are judged inappropriate for the entry into the study by the investigater.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median Survival Time of 2nd line therapy
- Secondary Outcome Measures
Name Time Method Clinical Benefit Response (CBR) Safety Time To Progression (TTP) Overall Survival (OS)