| Title |
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study |
| Protocole ID |
PDAC-LIV) |
| ClinicalTrials.gov ID |
NCT06349278 |
| Cancer Type(s) |
Pancreas |
| Phase |
Other |
| Stage |
|
| Study Type |
Clinical |
| Drug |
|
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| City |
|
| Principal Investigator |
Dr. Alexandre Brind’Amour
|
| Coordinator |
Maryse Gingras
418-525-4444 poste 67322
|
| Status |
Recruiting |
| Activation Date |
16-01-2024 |
| Eligibility 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.
|
| |
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Groupe d'étude en oncologie du Québec