Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06349278

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

Led by Laval University · Updated on 2024-04-16

15

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach for patients with pancreatic ductal adenocarcinoma (PDAC) who also have up to three resectable liver metastases. This prospective pilot study involves thorough assessments including blood tumor markers, triphasic CT scans, liver MRI, and possibly PET scans to determine tumor resectability and to exclude extrahepatic metastases. The goal is to study the effects of perioperative chemotherapy followed by surgery in this specific patient group. Participants will receive 12 cycles of perioperative FOLFIRINOX chemotherapy. After the first six cycles, tumor response is reassessed using imaging and tumor markers. Patients showing stable disease or partial response and significant tumor marker reduction will undergo pancreatic surgery (distal pancreatectomy or pancreatoduodenectomy) along with removal of liver metastases. The remaining six chemotherapy cycles are given either before or after surgery based on patient tolerance and tumor response. Throughout the study, patients will be monitored with blood tumor markers and CT scans every three months for two years, then every four months thereafter until recurrence or study end. The primary outcome measured is morbidity and mortality within 90 days after surgery. Secondary outcomes include overall survival up to three years post-surgery. Patients without adequate tumor response continue standard palliative systemic treatment. Total participation duration varies depending on individual treatment and follow-up outcomes.

CONDITIONS

Brief Title

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Resectable primary tumor based on triphasic CT-scan.
  • Three or fewer liver metastases.
  • Liver metastases removable by local excision or partial hepatectomy; patients with complete radiologic response not requiring liver resection are included.
  • No evidence of extrahepatic metastases.
  • Patient fit for pancreatic surgery with ECOG performance status 0 or 1.
  • Stable or partial tumor response on imaging after neoadjuvant FOLFIRINOX.
  • No new metastases after neoadjuvant FOLFIRINOX.
  • Blood tumor markers decreased by at least 80% or normalized after neoadjuvant FOLFIRINOX.
Not Eligible

You will not qualify if you...

  • Unable to obtain tissue diagnosis confirming PDAC before surgery.
  • Locally advanced disease detected on triphasic CT-scan.
  • More than three liver metastases.
  • Need for major hepatectomy such as right, left, central, or extended hepatectomy.
  • Suspicion or confirmation of extrahepatic metastases.
  • Patient unfit for pancreatic surgery with ECOG performance status 2 or higher.
  • Contraindication to receive FOLFIRINOX chemotherapy.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Surgery and immediate recovery period

Participants undergo pancreatic resection and non-anatomic liver resections following neoadjuvant FOLFIRINOX chemotherapy.

1 surgery visit and approximately 3 post-operative visits

Trial Site Locations

Total: 1 location

1

CHU de Québec

Québec, Quebec, Canada, G1R 2J6

Actively Recruiting

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Research Team

A

Alexandre Brind'Amour, MD, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.

Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...

https://pubmed.ncbi.nlm.nih.gov/30207593

Comparison between FOLFIRINOX and gemcitabine plus nab-paclitaxel including sequential treatment for metastatic pancreatic cancer: a propensity score matching approach.

Jung Won Chun, Sang Hyub Lee, Joo Seong Kim...

https://pubmed.ncbi.nlm.nih.gov/33975561

A multicenter propensity score analysis of FOLFIRINOX vs gemcitabine plus nab-paclitaxel administered to patients with metastatic pancreatic cancer: results from the NAPOLEON study.

Taiga Otsuka, Tsuyoshi Shirakawa, Mototsugu Shimokawa...

https://pubmed.ncbi.nlm.nih.gov/33483857