Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Due to more hematologic (neutropenia) and gastrointestinal toxicities, FOLFIRINOX is only administered in fit patients (age \< 75 years, ECOG Performance status 0-1, and bilirubin \< 1.5 ULN). However, elderly or frail patients represent more than half of patients with PDAC and are treated with gemcitabine monochemotherapy. Maintaining more than one drug (polychemotherapy) may improve survival and quality of life in this population. ALIX is a non-comparative randomized 2:1 phase II study. This study will assess the efficacy and safety of the polychemotherapy with XELOXIRI-3 versus gemcitabine as first-line chemotherapy in elderly or frail patients with locally advanced or metastatic PDAC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
chemotherapy with XELOXIRI-3 regimen
chemotherapy with Gemcitabine regimen
University Hospital of Besançon
Besançon, France
Hôpital Nord Franche-Comté
Montbéliard, France
CH Mulhouse
Mulhouse, France
CHU Nancy
Nancy, France
CHU Reims
Reims, France
6 months Progression-Free Survival (PFS) rate
Time frame: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)
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