Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Phase 2

Recruiting

• Conditions: Pancreatic Adenocarcinoma
• Interventions: Drug: GS; Drug: GnP

• Registration Number: NCT05268692
• Lead Sponsor: Kochi University

Brief 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

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GS	GS	gemcitabine plus S-1
GnP	GnP	gemcitabine plus nab-paclitaxel

Primary Outcome Measures

Name	Time	Method
overall survival	5 years	postoperative survival

Secondary Outcome Measures

Name	Time	Method
adverse events	up to 24 weeks	incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer

Trial Locations

Locations (1)

Takehiro Okabayashi; 🇯🇵 Kochi, Japan