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Trial Title:
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX
NCT ID:
NCT06349278
Condition:
Pancreas Adenocarcinoma
Pancreas Metastases
Pancreas Cancer
Conditions: Official terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Conditions: Keywords:
PDAC
Liver metastases
Pancreatic cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
One group will undergo intervention prospectively.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Pancreatic resection and non-anatomic liver resections.
Description:
Pancreatic resection and non-anatomic liver resections.
Arm group label:
Intervention
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Québec
Address:
City:
Quebec City
Zip:
G1R 2J6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Alexandre Brind'Amour
Phone:
+14185254444
Phone ext:
15925
Email:
godonco@chudequebec.ca
Investigator:
Last name:
Jean-François Ouellet, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jean-François Berthin Ouellet, MD
Email:
Sub-Investigator
Investigator:
Last name:
Isabelle Deshaies, MD
Email:
Sub-Investigator
Investigator:
Last name:
Carl Daigle, MD
Email:
Sub-Investigator
Investigator:
Last name:
Félix Couture, MD
Email:
Sub-Investigator
Investigator:
Last name:
Maxime Chénard-Poirier, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anne-Julie Simard
Email:
Sub-Investigator
Start date:
January 16, 2024
Completion date:
January 16, 2029
Lead sponsor:
Agency:
Laval University
Agency class:
Other
Source:
Laval University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349278
