Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX (PDAC-LIV)

April 12, 2024 updated by: Alexandre Brind'Amour, Laval University

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study

This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or < 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU de Québec
        • Contact:
        • Sub-Investigator:
          • Jean-François Ouellet, MD
        • Sub-Investigator:
          • Jean-François Berthin Ouellet, MD
        • Sub-Investigator:
          • Isabelle Deshaies, MD
        • Sub-Investigator:
          • Carl Daigle, MD
        • Sub-Investigator:
          • Félix Couture, MD
        • Sub-Investigator:
          • Maxime Chénard-Poirier, MD
        • Sub-Investigator:
          • Anne-Julie Simard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Resectable primary tumor based on triphasic CT-scan.
  • ≤ 3 liver metastases.
  • Liver resections can be performed by local excision or non-anatomical, partial hepatectomy. Patients with complete radiologic response after neoadjuvant FOLFIRINOX (FFX), therefore not requiring liver resection, will be included.
  • No evidence of extrahepatic metastases.
  • Patient fit for pancreatic resection (ECOG 0 or 1).
  • Stable or partial response on imaging after neoadjuvant FFX.
  • No new metastasis after neoadjuvant FFX
  • Blood tumor markers ≥ 80% decreased or within normal values after neoadjuvant FFX.

Exclusion Criteria:

  • Impossibility to obtain tissue diagnosis preoperatively confirming PDAC.
  • Locally advanced disease on triphasic CT-scan.
  • > 3 liver metastases.
  • Major hepatectomy required for liver metastases (right hepatectomy, left hepatectomy, central hepatectomy, extended right or left hepatectomy).
  • Suspicion or confirmation of extrahepatic metastases.
  • Patient unfit for pancreatic resection (ECOG 2 or more).
  • Contraindication to receive FFX.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients will undergo surgery for primary pancreatic cancer and liver metastases.
Procedure: Pancreatic resection and non-anatomic liver resections.
Pancreatic resection and non-anatomic liver resections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity and mortality
Time Frame: 90 days
Post-operative complications
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years after surgery
Overall survival
3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Alexandre Brind'Amour, MD, MSc, CHU de Québec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

January 16, 2026

Study Completion (Estimated)

January 16, 2029

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-7276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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