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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| China Medical University Hospital | OTHER |
| Kaohsiung Medical University | OTHER |
| Chang Gung Memorial Hospital |
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Multiple centers, uncontrolled, open-label, non-randomized single-arm study
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria)
Secondary objectives:
Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biweekly TS-1, Leucovorin and Gemcitabine (GSL) | Experimental | Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 to 7 Leucovorin 60 mg/d, orally twice daily on day 1 to 7 Every 14 days as one cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy: TS-1, Leucovorin and Gemcitabine | Drug | Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The progression-free survival time for elderly patients with advanced pancreatic cancer | up to 5.0 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall tumor response rate | up to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan | ||||
| Chang-Gung Memorial Hospital |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| OTHER |
| National Cheng-Kung University Hospital | OTHER |
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| Taipei |
| Taiwan |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |