Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

NCT ID: NCT06349278

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2029-01-16

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.

Conditions

Pancreas Adenocarcinoma; Pancreas Metastases; Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients will undergo surgery for primary pancreatic cancer and liver metastases.

Group Type: EXPERIMENTAL

Pancreatic resection and non-anatomic liver resections.

Intervention Type: PROCEDURE

Pancreatic resection and non-anatomic liver resections.

Interventions

Pancreatic resection and non-anatomic liver resections.

Pancreatic resection and non-anatomic liver resections.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Brind'Amour

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Brind'Amour, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec

Locations

CHU de Québec

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alexandre Brind'Amour, MD, MSc

Role: CONTACT

alexandre.brindamour.1@ulaval.ca

418-691-5370

Facility Contacts

Alexandre Brind'Amour

Role: primary

godonco@chudequebec.ca

+14185254444 ext. 15925

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Other Identifiers

2024-7276

Identifier Type: -

Identifier Source: org_study_id