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Recruiting

NCT Number: NCT06389552

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

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

Recruiting

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Key information

Conditions

Adjuvant Chemotherapy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul ST. Mary's Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Myung-Ah Lee

CONTACT

Myung-Ah Lee

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease-free survival

    Time frame: Day 1 to Week 88

    Duration of survival before pancreatic cancer recurrence or death

Secondary outcomes

  1. Overall survival

    Time frame: Day 1 to Week 88

    Duration of overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Soyeon Ahn

CONTACT

[email protected]

82-2-6477-0252

Yongan Jeong

CONTACT

[email protected]

82-2-6477-0255

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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