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

Phase 2

• Conditions: Resectable Pancreatic Adenocarcinoma
• Interventions: Drug: neoadjuvant modified FOLFIRINOX

• Registration Number: NCT05066802
• Lead Sponsor: Yonsei University

Brief Summary

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.

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 Timeline

• Study Start: 2020-05-11
• Status Verified: 2021-09
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Last Update Submitted: 2021-09-23
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified FOLFIRINOX	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).

Primary Outcome Measures

Name	Time	Method
R0 Resection Rate	Post surgery (within one week)	R0 resection rate with pathology report after curative aim surgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea; 🇰🇷 Seoul, Korea, Republic of