Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy
NCT05585554 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267
Last updated 2022-10-19
Summary
Ablative dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has shown to improve 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 next step is to determine how these results compare to chemotherapy alone.
This is a prospective, randomized controlled trial (2:1) comparing induction chemotherapy followed by ablative Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) versus chemotherapy alone in locally advanced pancreatic cancer patients. Overall survival outcomes at 2-years will be evaluated.
Conditions
Interventions
- RADIATION
-
MRIdian
Stereotactic MRI-guided On-table Adaptive Radiation Therapy delivered on MRIdian linac
Sponsors & Collaborators
-
Viewray Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-31
- Primary Completion
- 2028-08-31
- Completion
- 2028-12-31
- FDA Device
- Yes
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