Long-term Observational Study to Evaluate the DFS and OS... | NCT06389552

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

NCT06389552

Sponsor

HK inno.N Corporation

Status

Recruiting

Last Update Posted

Apr 29, 2024Actual

Enrollment

36Estimated

Phase

Not provided

Conditions

Adjuvant Chemotherapy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2023Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Apr 24, 2024

First Submission Date that Met QC Criteria

Apr 24, 2024

First Posted Date

Apr 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2024

Last Update Posted Date

Apr 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

110

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soyeon Ahn	Contact	82-2-6477-0252		soyeon.ahn@inno-n.com
Yongan Jeong	Contact	82-2-6477-0255		yongan.jeong@inno-n.com

Overall Officials

Name	Affiliation	Role
Myung-Ah Lee	Seoul St. Mary's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul ST. Mary's Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided