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

Primary Purpose

Resectable Pancreatic Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

neoadjuvant modified FOLFIRINOX

About this trial

This is an interventional treatment trial for Resectable Pancreatic Adenocarcinoma focused on measuring resectable pancreatic cancer, Neoadjuvant

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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].
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.

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified FOLFIRINOX

Arm Description

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).

Outcomes

Primary Outcome Measures

R0 Resection Rate

R0 resection rate with pathology report after curative aim surgery.

Secondary Outcome Measures

overall survival

overall survival is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.

Progression Free Survival

Progression Free Survival is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up

disease-free survival

disease-free survival is defined as time interval from operation day to tumor progression/death/last follow-up

Objective response rate

Objective response rate is defined as rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.

Full Information

NCT ID

NCT05066802

First Posted

September 23, 2021

Last Updated

September 23, 2021

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT05066802

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 11, 2020 (Actual)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Adenocarcinoma

Keywords

resectable pancreatic cancer, Neoadjuvant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

modified FOLFIRINOX

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

neoadjuvant modified FOLFIRINOX

Intervention Description

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.

Primary Outcome Measure Information:

Title

R0 Resection Rate

Description

R0 resection rate with pathology report after curative aim surgery.

Time Frame

Post surgery (within one week)

Secondary Outcome Measure Information:

Title

overall survival

Description

overall survival is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.

Time Frame

up to 2 years

Title

Progression Free Survival

Description

Progression Free Survival is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up

Time Frame

up to 2 years

Title

disease-free survival

Description

disease-free survival is defined as time interval from operation day to tumor progression/death/last follow-up

Time Frame

up to 2 years

Title

Objective response rate

Description

Objective response rate is defined as rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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]. 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Choong-kun Lee

Phone

+82-2-2228-8133

cklee512@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Choong-kun Lee

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Choong-kun Lee

Phone

+82-2-2228-8133

cklee512@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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