Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients

April 24, 2024 updated by: HK inno.N Corporation

A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective

This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is multi-center, prospective, long-term follow-up observational study.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary's Hospital
        • Contact:
          • Myung-Ah Lee
        • Principal Investigator:
          • Myung-Ah Lee

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

110

Description

Inclusion Criteria:

  • Age over 19 at the time of obtaining the informed consent form
  • Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery
  • ECOG 0 or 1
  • Scheduled to RO or R1 resection
  • Organ function capable of chemotherapy

Exclusion Criteria:

  • FOLFIRINOX contraindications among the drug approval requirements
  • Palliative Therapy
  • Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: Day 1 to Week 88
Duration of survival before pancreatic cancer recurrence or death
Day 1 to Week 88

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Day 1 to Week 88
Duration of overall survival
Day 1 to Week 88

Collaborators and Investigators

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

Sponsor

HK inno.N Corporation

Investigators

  • Study Chair: Myung-Ah Lee, Seoul St. Mary's Hospital

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)

September 25, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IN_CTP_N01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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