Stereotactic MRI-Guided On-Table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer - Medical / Health Care
Ongoing Clinical Study
ViewRay has a sponsored study titled “Prospective phase II Study of Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) for Patients with Borderline or Inoperable Locally Advanced Pancreatic Cancer.”
High-dose magnetic resonance imaging (MRI) guided ...
High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity.
The goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.
Patients with borderline resectable or inoperable locally advanced pancreatic cancer who are 18 years and older and meet the inclusion and exclusion criteria noted within the study description.
In this single-arm study, participants will receive radiation therapy using integrated magnetic resonance imaging (ViewRay’s MRIdian MR-Guided Radiation Therapy System) at a dose of 50 Gray in 5 fractions (treatment sessions). Fractions will be delivered at least twice per week and with at least 18 hours between treatments. Each participant will be aligned in the treatment system with MRI-guidance. On-table adaptive replanning will be used when clinically indicated. In all patients, real-time MR-imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam, as necessary.
The primary outcome measure of the study is grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment. Secondary measures include overall survival at two years, distant progression-free survival at six months, and changes in patient-reported quality of life (pre-treatment to 12 months post-treatment and for longer periods up to five years).