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

NCT05066802 | Unknown Phase 2 DMC

• 1 other identifier: 4-2019-0485
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Pancreatic Adenocarcinoma

Keywords

resectable pancreatic cancer; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  R0 resection rate with pathology report after curative aim surgery.

  Post surgery (within one week)

Secondary Outcomes (4)

• overall survival

  up to 2 years

• Progression Free Survival

  up to 2 years

• disease-free survival

  up to 2 years

• Objective response rate

  3 months

Study Arms (1)

modified FOLFIRINOX

EXPERIMENTAL

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

Interventions

neoadjuvant modified FOLFIRINOX DRUG

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.

modified FOLFIRINOX

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[CHA\].
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

Seoul, South Korea

RECRUITING

Study Officials

• Choong-kun Lee

  Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Choong-kun Lee

CONTACT

+82-2-2228-8133; cklee512@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: May 11, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2023
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)