NCT05268692

Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Kochi University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	GS	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.
DRUG	GnP	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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2022-03-07
• Last updated: 2022-03-07

Locations

1 site across 1 country: Japan