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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: neoadjuvant modified FOLFIRINOX

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination

2. Pancreatic adenocarcinoma patients evaluated as resectable according to the following criteria in imaging tests including CT or MRI (NCCN guideline criteria, if all of the following criteria are satisfied) A. No tumor contact with the major arterial structures of the Celiac axis [CA], superior mesenteric artery [SMA], and common hepatic artery [CHA].

   B. When there is no contact between the tumor and the major vein of the superior mesenteric vein (SMV) or portal vein (PV), or within 180° even if there is contact, and there is no venous atypicality.

3. Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.
4. Patients whose ECOG activity ability index is 0 to 1
5. Patients who are willing and able to provide written informed consent for this study.
6. Patients over the age of 19 at the time of signing the subject consent form.
7. Patients with evaluable lesions according to RECIST 1.1.
8. Patients with adequate organ function.

Exclusion Criteria:

1. Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
2. Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
3. Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
4. Patients who have participated in a study in which investigational drugs are used and are currently receiving investigational drugs or used investigational drugs or medical devices within 4 weeks prior to the first administration of this investigational drug.
5. Those who received chemotherapy, targeted small molecule agents, or radiotherapy within 2 weeks prior to Day 1 of the study, or who have not yet recovered (Grade 1 or lower or baseline level) from adverse reactions due to previously administered drugs patient.
6. Patients with known aggravation within the past 3 years or other malignant tumors requiring active treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Choong-kun Lee, Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2020
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (ACTUAL): October 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Neoadjuvant; resectable pancreatic cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Antineoplastic Agents; Folfirinox
• Other Study ID Numbers: 4-2019-0485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No