JPRN-UMIN000000655
Completed
Phase 3
Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer - Randomized phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 for pancreatic cancer (JASPAC 01)
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)0 sites360 target enrollmentApril 1, 2007
ConditionsResected pancreatic cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Resected pancreatic cancer
- Sponsor
- Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
- Enrollment
- 360
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Exclusion criteria are as folllows: 1\) Prior history of gemcitabine therapy or S\-1 therapy 2\) Recurrent disease on enrollment 3\) Massive ascites or pleural effusion 4\) Plumonary fibrosis or interstitial pneumonia 5\) Severe diarrhea 6\) NYHA III or IV cardiac function 7\) Myocardial infarction within six months 8\) Severe infection 9\) Severe diabetes 10\) Blood transfusion within two weeks 11\) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 12\) Severe mental disorder 13\) Severe drug allergy 14\) Other active malignancy 15\) Pregnancy, breast feeding, or women who desire to preserve fecundity 16\) Men who desire to have children 17\) Regular use of frucitocin, fenitoin or warfarin 18\) Inadequate physical condition, as diagnosed by primary physician
Outcomes
Primary Outcomes
Not specified
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