Extending Outcomes for Pancreas Cancer Patients With Nominal Oligometastatic Disease (EXPAND): A Randomized Phase III Trial

Primary Objectives: To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in PFS compared to systemic therapy alone. Secondary Objectives: Key secondary objective: To determine whether, in patients with oligometastatic pancreatic ductal adenocarcinoma, MDT to all sites of disease confers a benefit in OS compared to systemic therapy alone. To assess safety/tolerability of MDT in patients with oligometastatic PDAC. To assess time to new lesion formation between treatment arms. To assess time to next-line systemic therapy between treatment arms. To assess incidence and duration of time off systemic therapy between treatment arms. To assess incidence and duration of time on maintenance systemic therapy between treatment arms. To assess time to local failure between treatment arms for lesions present at enrollment/baseline. To compare quality of life (QOL) between treatment arms. To assess the above primary and secondary objectives, as well as exploratory objectives, which may be differential based on receipt of different forms of MDT in the MDT arm (e.g,. surgery, external beam radiotherapy, etc). Exploratory Objectives: To identify predictive/prognostic biomarkers correlated with a benefit for MDT. To investigate changes in biomarker profile over time and in response to MDT.