JPRN-UMIN000004410
Completed
Phase 3
Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04) - Phase III study of gemcitabine and S-1 combination therapy for resected pancreatic cancer
Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP)0 sites300 target enrollmentOctober 20, 2010
ConditionsResected pancreatic cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Resected pancreatic cancer
- Sponsor
- Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP)
- Enrollment
- 300
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) History of serious complications related to surgery 2\) Patients under treatment with phenytoin, warfarin potassium or flucytosine. 3\) Uncontrolled watery diarrhea 4\) Sever mental disorder 5\) Active infection 6\) Serious complications 7\) Pulmonary fibrosis or interstitial pneumonia 8\) Clinically significant pleural effusions or ascites 9\) Active double cancer (synchronous double cancer or asynchronous double cancer with disease\-free duration of 2 years or less) 10\) History of chemotherapy or radiotherapy for other malignant disease within one year 11\) Unable to receive contrast enhanced CT nor MRI due to allergic reaction to contrast medium 12\) Pregnant females, possibly pregnant females, females wishing to become pregnant, and males that are currently attempting to produce a pregnancy 13\) Inadequate physical condition, as diagnosed by primary physician
Outcomes
Primary Outcomes
Not specified
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