| TITRE |
(EN) Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX: a Prospective, Pilot Study |
| PROTOCOLE ID |
PDAC-LIV |
| CLINICAL TRIAL.gov ID |
NCT06349278 |
| TYPE(S) DE CANCER |
Pancréas |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Alexandre Brind’Amour
|
| COORDONATEUR(RICE) |
Maryse Gingras
maryse.gingras@chudequebec.ca
418-525-4444 poste 15781
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
