Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

This research study is a Phase II clinical trial. Phase II clinical trials test the safety
and effectiveness of an investigational intervention to learn whether the intervention works
in treating metastases of the bone. "Investigational" means that the intervention is being
studied.

SBRT is an advanced technique that allows for more precise delivery of radiation than with
standard radiation therapy. In comparison to standard radiation therapy, it allows us to give
higher doses of radiation to a tumor while limiting the radiation dose going to the
surrounding normal tissues. This technology has been made possible by advances in imaging and
treatment capabilities on the radiation treatment machines. SBRT works just as standard
radiation therapy works by damaging cancer cells.

SBRT has been used to deliver radiation to people with cancer in the lung and those with
metastases in the spine or liver. Studies of those groups have shown low rates of side
effects with good rates of killing the cancer in that area and preventing it from coming
back. In the current research study, the investigators are looking to further evaluate how
well this type of radiation controls disease in bone and whether the toxicity (side effects)
of SBRT differs from that of standard treatment. The investigators hypothesis is that
toxicity might be less, as less normal tissue receives radiation with SBRT than with standard
treatment. It is important to note that SBRT, just like standard radiation therapy for the
participant disease, is being used to attempt to stop the growth of cancer cells in a bone
metastasis and relieve or prevent any symptoms (ex. pain) associated with bone metastases.
The goal of the SBRT is not to cure the participant cancer. The primary goal of the study is
to see how well SBRT controls the disease in the bone, and the investigators also want to
analyze its ability to control disease symptoms without added toxicity.

Inclusion Criteria:

- Both cohorts:

--≥18 years of age

- ECOG performance status ≤2

- Pathologically proven metastatic solid tumor (non-hematologic malignancy) of the
bone (spine or non-spine bone)

- Bony metastatic lesions must be ≤6 cm in maximum dimension and evaluable on
either a CT or MRI scan; metastatic lesions in the spine must involve ≤3
contiguous vertebral bodies

- No other active malignancy within the past 2 years, except for non-melanoma skin
cancers or carcinoma in situ of the cervix

- Ability to understand and the willingness to sign a written informed consent
document

- Surgery to the lesion in question is allowed if size criteria outlined above are
met

- Not currently pregnant or breast feeding

- Cohort 1: Oligometastatic state

- Oligometastatic state is defined by ≤ 3 active sites of disease, including the
primary site

- Agreement of both the Chow et al.15 and TEACHH16 models, indicating a median life
expectancy of >3 months

- Among patients with multiple sites of metastatic disease, the other sites that
will not be treated on this protocol have either been previously treated or are
planned for local treatment

- Cohort 2: Re-irradiation

- Previous radiation in the current area of disease requiring radiation

- Life expectancy of >3 months as defined by agreement of both the Chow et al.15
and TEACHH16 models

Exclusion Criteria:

- SBRT target size >6 cm in maximum diameter (or >100 cc in volume)

- Hematologic malignancies (including lymphoma, multiple myeloma)

- Prior RT of greater dose intensity than 100 Gy2 based on a biological effective dose
(BED) calculation [BED (Gy2) = nd x (1+d/α/ß; where n=number of fractions, d=dose per
fraction, α/ß=2)]

- Epidural tumor <2 mm from spinal cord

- Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent
hormonal therapies are allowed)

- Inability to lie flat and still for treatment delivery despite anti-anxiety and/or
pain medications

- Non-English speakers are excluded from this study due to use of questionnaires which
have not been validated in other languages.

- Patients lacking the capacity to describe their symptoms are excluded as that
precludes them (or anyone on their behalf) from filling out the validated
questionnaires about symptoms/toxicity.

- Pregnant women are excluded from this study because radiotherapy has the potential for
teratogenic or abortifacient effects.

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances: if they have been disease-free for at least 2 years and are
deemed by the investigator to be at low risk for recurrence of that malignancy; or if
diagnosed and treated within the past 2 years for cervical cancer in situ or basal
cell or squamous cell carcinoma of the skin.