Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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.