Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP

February 24, 2022 updated by: Takehiro Okabayashi, Kochi University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kochi, Japan, 781-8555
        • Recruiting
        • Takehiro Okabayashi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 5 years
postoperative survival
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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