Pancreatic Cancer Clinical Trial
Official title:
A Randomized Controlled Phase II Study of Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
In light of this new technology and preliminary findings of low toxicity of online, adaptive,
magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the
investigators propose to compare this technique to online MR-guided stereotactic body
radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment times
for patients and comprises an increased burden on technical and clinical staff. Although
preliminary trial results are encouraging, it remains unclear if the dosimetric benefits of
online-adaptive planning studies will translate to measurable improvements in clinical
outcomes that merit its routine use. In our preliminary study, plan adaptation was most often
required when tumors were adjacent to the gastrointestinal tract (the esophagus to the
sigmoid colon), as those structures were most commonly the dose-limiting structures and were
noted to change in location on a day-to-day basis. For these reasons, abdominal disease sites
have historically highlighted the limitations of SBRT. Specifically, the investigators will
enroll patients with oligometastatic or unresectable primary disease of the non-liver abdomen
to a randomized, prospective trial.
Patients will be randomized to one of two treatment arms, in which they will receive either
online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will
undergo MRI simulation and MRI treatment localization with online MR monitoring and/or
gating. All patients will be treated in five fractions over one to two weeks. By adhering to
strict normal tissue constraints, the investigators expect toxicity to be within the current
standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients
who undergo adaptation based on daily anatomic changes.
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