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Recruiting NCT06389552

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

— Observational Adjuvant Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Adjuvant Chemotherapy. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Disease-free survival [Time frame: Day 1 to Week 88]
Secondary outcome measures (1)
  • Overall survival [Time frame: Day 1 to Week 88]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

South Korea · 1 center
  • Seoul ST. Mary's Hospital — Seoul

Identifiers

NCT: NCT06389552 · IN_CTP_N01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗