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ACTIVE NOT RECRUITING
NCT03621644
NA

Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

Sponsor: Viewray Inc.

View on ClinicalTrials.gov

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

Interventions

RADIATION

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