NCT06389552

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Sep 2023Dec 2027

Study Start

First participant enrolled

September 25, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

April 24, 2024

Last Update Submit

April 24, 2024

Conditions

Adjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    Duration of survival before pancreatic cancer recurrence or death

    Day 1 to Week 88

Secondary Outcomes (1)

  • Overall survival

    Day 1 to Week 88

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

110

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Myung-Ah Lee

    Seoul St. Mary's Hospital

    STUDY CHAIR

Central Study Contacts

Soyeon Ahn

CONTACT

82-2-6477-0252soyeon.ahn@inno-n.com

Yongan Jeong

CONTACT

82-2-6477-0255yongan.jeong@inno-n.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 29, 2024

Study Start

September 25, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)