Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies

In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body
radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine
will be evaluated. To best assess this technology, we will focus on three specific
oligometastatic disease sites that have historically highlighted the limitations of SBRT.
Specifically, we will enroll patients with oligometastatic disease of the central thorax,
liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and
MRI treatment gating. Patients will be treated in five fractions over one to two weeks. By
adhering to strict normal tissue constraints, expected toxicity will be within the current
standard of care, but allow adaptation based on daily anatomic changes. The prescription
dose will be determined based on above hard normal tissue constraints, and capped at 15 Gy
per fraction. Although our long-term goal will be to achieve improved local control and
disease-free survival with reduced toxicity, the present study will be driven by short-term
goals of demonstrating feasibility of an on-table adaptive approach, which has never
previously been reported.

Inclusion Criteria:

- Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven
primary disease histology of solid tumor categorization with the exception of small
cell cancers.

- Must be deemed medically fit for SBRT to the liver or lung by the treating physician.

- At least 18 years of age.

- Karnofsky performance status > 60 (see Appendix A)

- Must have completed any systemic therapy at least one week prior to planned start of
SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for
at least one week following end of SBRT (two weeks preferred).

- Able to understand and willing to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

- Primary disease of hematologic origin, lymphoma, or small cell cancer.

- Past history of radiotherapy within the projected treatment field of any of the
disease sites to be treated by MRI-guided, online adaptive SBRT.

- Widespread progressive disease, i.e., more than 3 sites of progressive disease (more
than 3 sites of disease are permitted provided there are no more than 3 sites of
progressive disease).

- Currently receiving any other investigational agents.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14
days of study entry.

- Medical contraindication to undergoing MR imaging.