Randomized phase II trial of TS-1 monotherapy versus TS-1 plus gemcitabine therapy in patients with gemcitabine-resistant advanced pancreatic cancer
- Conditions
- Patients with unresectable advanced pancreatic cancer (Stage IV, TNM Classification) who were primarily resistant to gemcitabine monotherapy
- Registration Number
- JPRN-UMIN000001103
- Lead Sponsor
- Keio University School of Medicine, Department of Medicine, Division of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 80
Not provided
Exclusion criteria are as follows: 1) Prior history of radiation therapy to pancreatic cancer 2) Presence of other active malignancy 3) Presence of severe complications such as plumonary fibrosis, interstitial pneumonia, intestinal paralysis, uncontrolled diabetes, uncontrolled hypertension, myocardial infarction within six months, unstable angina, severe infection, renal failure, liver failure, , etc 4) Past history of allergic reaction to gemcitabine 5) Regular use of frucitocin, fenitoin or warfarin 6) Past history of radiation therapy to the lung(s). 7) Massive ascites or pleural effusion 8) Severe diarrhea 9) active intestinal bleeding 10) Pregnancy, breast feeding, or women who desire to preserve fecundity or men who desire to have children 11) Severe mental disorder 12) regular use of steroids 13) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease control rate
- Secondary Outcome Measures
Name Time Method progression-free survival, overall survival, adverse event, QO