Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

Recruiting now · Not applicable

Conditions studied: Pancreas Adenocarcinoma, Pancreas Metastases, Pancreas Cancer

In brief

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.

Key facts

Study ID

NCT06349278

Run by

Laval University

People needed

15

Starts

2024-01-16

Expected to finish

2029-01-16

Last updated by the study team

2024-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CHU de Québec — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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