RecruitingPhase 2Phase 3NCT05268692

Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP


Sponsor

Kochi University

Enrollment

500 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria1

  • elective pancreatectomy for pancreatic cancer

Exclusion Criteria1

  • 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.

Interventions

DRUGGS

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.

DRUGGnP

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.


Locations(1)

Takehiro Okabayashi

Kochi, Japan

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NCT05268692


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