Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

Launched by LAVAL UNIVERSITY · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment approach for patients with pancreatic cancer that has spread to the liver. Specifically, it looks at whether giving patients a chemotherapy regimen called FOLFIRINOX before surgery can help them achieve better outcomes. The study will include patients who have a confirmed diagnosis of pancreatic ductal adenocarcinoma and have tumors that can be surgically removed, along with three or fewer liver metastases (cancer spots in the liver). Eligible participants will undergo imaging tests to ensure their cancer is manageable and will receive a total of 12 cycles of chemotherapy, with surgery planned based on how well they respond.

Participants can expect close monitoring throughout the trial. They will receive regular scans and blood tests to check their tumor markers—substances in the blood that can indicate cancer activity—before and after chemotherapy. If their tumors show improvement, they will proceed to surgery to remove the pancreatic tumor and any liver metastases. After surgery, patients will continue to be monitored for two years to track their recovery and watch for any signs of cancer returning. If they do not respond to the chemotherapy, they will receive standard treatment options. Overall, this study aims to find out if this combined treatment approach can lead to better surgical outcomes for patients with pancreatic cancer and liver metastases.

Gender

ALL

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.