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

Resectable Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066802
• Other study ID #: 4-2019-0485
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2021
• Source: Yonsei University
• Contact: Choong-kun Lee
• Phone: +82-2-2228-8133
• Email: cklee512[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Resectable Pancreatic Adenocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 Resection Rate	R0 resection rate with pathology report after curative aim surgery.	Post surgery (within one week)
Secondary	overall survival	overall survival is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.	up to 2 years
Secondary	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
Secondary	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
Secondary	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