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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05066802
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Pancreatic Adenocarcinoma	Drug: neoadjuvant modified FOLFIRINOX	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Trial of Neoadjuvant Modified FOLFIRINOX Chemotherapy for Resectable Pancreatic Adenocarcinoma
• Actual Study Start Date: May 11, 2020
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. R0 Resection Rate [Post surgery (within one week)]

   R0 resection rate with pathology report after curative aim surgery.

Secondary Outcome Measures

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.

2. 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

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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].

1. 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.

1. Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer.

2. Patients whose ECOG activity ability index is 0 to 1

3. Patients who are willing and able to provide written informed consent for this study.

4. Patients over the age of 19 at the time of signing the subject consent form.

5. Patients with evaluable lesions according to RECIST 1.1.

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT05066802
• Other Study ID Numbers: 4-2019-0485
• First Posted: Oct 4, 2021
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yonsei University: resectable pancreatic cancer; Neoadjuvant
• Additional relevant MeSH terms: Adenocarcinoma; Folfirinox

Study Results

No Results Posted as of Oct 4, 2021