NCT06593431

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The EXPAND trial (EXtending outcomes for PAncreas cancer patients with Nominal oligometastatic Disease) is a randomized phase III trial assessing the efficacy of MDT to improve PFS and OS for patients with oligometastatic pancreatic ductal adenocarcinoma (PDAC).

Detailed description

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.

Conditions

• Pancreas Cancer
• Oligometastatic

Interventions

Type	Name	Description
RADIATION	Consolidative Radiation	Participants will receive treatment through radiation therapy

Timeline

• Start date: 2024-10-23
• Primary completion: 2029-06-29
• Completion: 2029-06-29
• First posted: 2024-09-19
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States