The Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) Trial, a multi-center, prospective clinical trial for locally advanced or borderline pancreatic cancer, will explore the clinical benefits of precise, high-dose radiation therapy enabled by MR-guidance combined with daily on-table adaptive dosing in the treatment of pancreatic cancer.
Retrospective analysis of precise, high-dose MR-guided radiation therapy delivered using adaptive dose planning has shown promising results with locally advanced pancreatic cancer, according to the Cleveland, Ohio, company. These data suggest the potential for improving overall survival of patients receiving lower radiation doses, without increasing the rate of serious gastrointestinal toxicity, ViewRay said in a statement. The SMART trial will also track treated patients’ quality of life over a five-year period.
“High-definition MR and daily treatment plan adaptation allow us to deliver ablative radiation doses safely to pancreatic cancer patients for the first time ever,” said Parag Parikh, M.D., co-principal investigator of the study and director of GI radiation oncology and MR-guided radiation therapy at the Henry Ford Cancer Institute in Detroit. “Through the SMART trial, we will build upon the promising experience from UCLA, Washington University, Amsterdam UMC, University of Miami and University of Wisconsin by further exploring MRIdian’s impact on associated toxicity, local control and patient outcomes in pancreatic cancer at multiple institutions around the world.”
The SMART trial is the first prospective, multi-institutional study to deliver ablative doses of radiation to pancreatic cancer patients. It aims to enroll 133 participants with borderline resectable or inoperable locally advanced pancreatic cancer. In the single-arm study, participants will receive radiation therapy at a dose of 50 Gray in 5 fractions (treatment sessions) using ViewRay’s MRIdian. 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.
The trial’s primary outcome measure is grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment, with secondary measures including overall survival at two years, distant progression-free survival at six months, and changes in patient-reported quality of life. 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).
“Early evidence on the use of MRIdian to treat locally advanced pancreatic cancer suggests the potential for significantly prolonged survival and lower toxicity rates. Through this rigorously designed study, we hope to further validate the long-term benefits of treatment on the MRIdian,” said ViewRay president and CEO Scott Drake in the statement. “We believe MRIdian’s unique combination of real-time visualization, automated beam control, and daily on-table treatment adaptation has the potential to become the standard of care in radiation oncology.”
Along with Parikh, the trial is led by Percy Lee, M.D. from the University of California Los Angeles.