Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: GS; Drug: GnP

Detailed Description

gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kochi, Japan, 781-8555
    • Recruiting
    • Takehiro Okabayashi
    • Contact: Takehiro Okabayashi; Phone Number: +81- 88-837-3000; Email: tokabaya@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GS; gemcitabine plus S-1	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.
Active Comparator: GnP; gemcitabine plus nab-paclitaxel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	postoperative survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	incidence of adverse events for neoadjuvant chemotherapy for pancreatic cancer	up to 24 weeks

Collaborators and Investigators

• Sponsor: Kochi University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Neoadjuvant
• Other Study ID Numbers: GSGnP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No