A Phase 2 Trial Of Neoadjuvant Modified FOLFIRINOX Chemotherapy For Resectable Pancreatic Adenocarcinoma

Study Overview

A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma

Within the next decade, pancreatic ductal adenocarcinoma (PDAC) is expected to rise to the second leading cause of cancer-related mortality. To increase the survival, various peri-operative treatments have been tested, and adjuvant FOLFIRINOX or gemcitabine plus capecitabine is now standard of care after surgical resection for localized PDAC. Even with superior survival among various disease extent of PDAC, resectable PDAC still shows poor outcomes with surgery followed by adjuvant chemotherapy. This phase II study is investigating the role of modified-FOLFIRINOX as neoadjuvant treatment for resectable PDAC.

This phase II study is designed to evaluate the efficacy and safety of modified FOLFIRINOX as neoadjuvant treatment for resectable pancreatic cancer.

Resectable Pancreatic Adenocarcinoma

DRUG: neoadjuvant modified FOLFIRINOX

4-2019-0485

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-09-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-09-23
First Submitted that Met QC Criteria 2021-09-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-10-04
First Posted (ACTUAL) 2021-10-04	Results First Posted N/A	Last Verified 2021-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: modified FOLFIRINOX oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks).	DRUG: neoadjuvant modified FOLFIRINOX oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks) before surgery.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: modified FOLFIRINOX

oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks).

DRUG: neoadjuvant modified FOLFIRINOX

oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks) before surgery.

Primary Outcome Measures	Measure Description	Time Frame
R0 Resection Rate	R0 resection rate with pathology report after curative aim surgery.	Post surgery (within one week)

Secondary Outcome Measures	Measure Description	Time Frame
overall survival	overall survival is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.	up to 2 years
Progression Free Survival	Progression Free Survival is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up	up to 2 years
disease-free survival	disease-free survival is defined as time interval from operation day to tumor progression/death/last follow-up	up to 2 years
Objective response rate	Objective response rate is defined as rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.	3 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Choong-kun Lee

Phone Number: +82-2-2228-8133

Email: cklee512@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Choong-kun Lee, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record