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The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.
gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS | Active Comparator | gemcitabine plus S-1 |
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| GnP | Active Comparator | gemcitabine plus nab-paclitaxel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS | Drug | drip infusion of gemcitabine plus oral administration of S-1 S-1 received S-1 orally twice daily at a dose calculated according to body-surface area (BSA) (< 1.25 m2, 60 mg/d; ≥ 1.25 to < 1.5 m2, 80 mg/d; ≥ 1.5 m2, 100 mg/d) on days 1 through 14 of a 21-day cycle gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1 and 8of a 21-day cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | postoperative survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer | up to 24 weeks |
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Inclusion Criteria:
elective pancreatectomy for pancreatic cancer
Exclusion Criteria:
a previous cancer surgery a body weight loss of >10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takehiro Okabayashi | Recruiting | Kochi | 781-8555 | Japan |
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| GnP | Drug | drip infusion of both gemcitabine and nab-paclitacel gemcitabine received gemcitabine intravenously at a dose of 800 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. nab-paclitaxel received nab-paclitaxel intravenously at a dose of 100 mg/m2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle. |
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