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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06389552

Enrollment

Registered

2024-04-29

Start date

2023-09-25

Completion date

2027-12-31

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant Chemotherapy

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall survival	Day 1 to Week 88	Duration of overall survival

Countries

South Korea

Contacts

Primary ContactSoyeon Ahn

soyeon.ahn@inno-n.com82-2-6477-0252

Backup ContactYongan Jeong

yongan.jeong@inno-n.com82-2-6477-0255

Outcome results