ViewRay, Inc. announces the enrollment of the first patient in the Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) Trial, a multi-center clinical trial for locally advanced or borderline pancreatic cancer. The trial will explore the clinical benefits of high-dose radiation therapy enabled by MR-guidance, combined with daily on-table adaptation in the treatment of pancreatic cancer.
Retrospective analysis of high-dose MR-guided radiation therapy delivered using adaptive dose planning has shown promising results with locally advanced pancreatic cancer, suggesting the potential for improving overall survival relative to patients receiving lower radiation doses, without increasing the rate of serious gastrointestinal toxicity. The compelling nature of the retrospective data prompted the SMART trial, aimed at tracking quality of life over a five-year period in a controlled manner.
“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,” says Parag Parikh, M.D., co-PI of the study and director of gastrointestinal 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 five fractions (treatment sessions) using ViewRay’s MRIdian.
On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI 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.
“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,” says Scott Drake, president and CEO of ViewRay.