Clinical trial NCT06349278: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
Official title: Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Adenocarcinoma
Pancreas Metastases
Pancreas Cancer
Keywords: PDAC
Liver metastases
Pancreatic cancer
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group will undergo intervention prospectively.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity and mortality
timeFrame: 90 days
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: CHU de Québec
state: Quebec
Study officials:
affiliation: CHU de Québec
name: Alexandre Brind'Amour, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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