RWF_VR C2T2 - SMART

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

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.

Inclusion Criteria:
• Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible as long as lymph nodes are adjacent to primary tumor.
• Greater than or equal to 3 months of systemic chemotherapy
• Normal bone marrow and organ function

Exclusion Criteria:
• Distant metastatic disease as assessed by staging positron emission tomography / computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
• Carbohydrate antigen (CA19.9) > 500 U/ml.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Currently receiving any other investigational agents.
• Major surgery within 4 weeks prior to first day of treatment.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Medical/psychological contraindication to magnetic resonance imaging (MRI).
Phase II
NCT03621644
Oncology
Gastrointestinal
Kristina Young, M.D., Ph.D.
Viewray Inc.
Mary Mccormick
  • Providence Portland Medical Center