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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    27
  • sponsor
    Yonsei University
Updated on 10 October 2021

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.

Details
Condition Resectable Pancreatic Adenocarcinoma
Treatment neoadjuvant modified FOLFIRINOX
Clinical Study IdentifierNCT05066802
SponsorYonsei University
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with pancreatic ductal adenocarcinoma confirmed by histological or cytopathological examination
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]
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
Patients who have not undergone surgical resection and systemic chemotherapy for pancreatic cancer
Patients whose ECOG activity ability index is 0 to 1
Patients who are willing and able to provide written informed consent for this study
Patients over the age of 19 at the time of signing the subject consent form
Patients with evaluable lesions according to RECIST 1.1
Patients with adequate organ function

Exclusion Criteria

Histologic diagnosis other than pancreatic ductal adenocarcinoma (eg, neuroendocrine tumor, etc.)
Patients with distant metastases including central nervous system (CNS) metastases or peritoneal metastases
Patients with moderate acute or chronic medical conditions or abnormal findings on examination, which are judged to affect the results of this study
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
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
Patients with known aggravation within the past 3 years or other malignant tumors requiring active treatment
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