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

Adjuvant Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389552
• Other study ID #: IN_CTP_N01
• Status: Recruiting
• Start date: September 25, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: HK inno.N Corporation
• Contact: Soyeon Ahn
• Phone: 82-2-6477-0252
• Email: soyeon.ahn[@]inno-n.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Chemotherapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Duration of survival before pancreatic cancer recurrence or death	Day 1 to Week 88
Secondary	Overall survival	Duration of overall survival	Day 1 to Week 88