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Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer
Sponsor: Viewray Inc.
Summary
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.
Official title: Prospective Phase II Study of Stereotactic Magnetic Resonance Imaging (MRI) Guided On-table Adaptive Radiation Therapy (SMART) for Patients With Borderline or Inoperable Locally Advanced Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
133
Start Date
2019-01-01
Completion Date
2027-01
Last Updated
2022-10-14
Healthy Volunteers
No
Conditions
Interventions
Stereotactic MRI-guided On-table Adaptive Radiation Therapy
Radiation therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian or MRIdian Linac). The prescribed dose will be 50 Gray (Gy) in 5 fractions. Stereotactic body radiotherapy (SBRT) fractions will be delivered at least twice per week, and with at least 18 hours between fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.
Locations (13)
UCLA
Los Angeles, California, United States
University of Miami
Miami, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health
Orlando, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health Sciences
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Cornell University
New York, New York, United States
Providence Portland Cancer Center
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Wisconisin
Madison, Wisconsin, United States
Assuta Medical Center
Tel Aviv, Israel