Surgery for pancreatic cancer with liver metastases after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates patients with resectable pancreatic ductal adenocarcinoma and up to three liver metastases who will undergo surgery following neoadjuvant chemotherapy with FOLFIRINOX. Patients will receive a total of 12 cycles of chemotherapy, with imaging assessments to monitor tumor response before surgery. The study aims to determine the feasibility and outcomes of surgical resection in this patient population. The approach includes thorough preoperative evaluations using various imaging techniques to ensure optimal patient selection for surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Québec
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Alexandre Brind'Amour, MD, MSc — CHU de Québec
• Study coordinator: Alexandre Brind'Amour, MD, MSc
• Email: alexandre.brindamour.1@ulaval.ca
• Phone: 418-691-5370

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.