Actively Recruiting
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
Led by Laval University · Updated on 2024-04-16
15
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
Who Can Participate
Eligibility Criteria
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 can be removed by local excision or partial hepatectomy.
- Patients with complete radiologic response after neoadjuvant FOLFIRINOX not requiring liver resection are included.
- No evidence of metastases outside the liver.
- Patient is fit for pancreatic surgery (ECOG 0 or 1).
- Stable or partial response seen on imaging after neoadjuvant FOLFIRINOX.
- No new metastases after neoadjuvant FOLFIRINOX.
- Blood tumor markers decreased by 80% or normalized after neoadjuvant FOLFIRINOX.
You will not qualify if you...
- Unable to obtain tissue diagnosis confirming PDAC before surgery.
- Locally advanced disease on triphasic CT-scan.
- More than three liver metastases.
- Major hepatectomy needed for liver metastases (e.g., right, left, central, extended hepatectomy).
- Suspicion or confirmation of metastases outside the liver.
- Patient unfit for pancreatic surgery (ECOG 2 or higher).
- Contraindication to receive FOLFIRINOX chemotherapy.
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Québec
Québec, Quebec, Canada, G1R 2J6
Actively Recruiting
Research Team
A
Alexandre Brind'Amour, MD, MSc
CONTACT
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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