Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain

Inclusion Criteria:

- Histologically confirmed solid tumor malignancy with greater than 5 sites of
metastatic disease detected on cross-sectional imaging.

- Has high risk bone metastases that are asymptomatic or minimally symptomatic (not
requiring opioids). High risks metastases are defined as: 1. bulkiest sites of osseous
disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck),
shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long
bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia,
fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1)
and/or disease with posterior element involvement.

- ECOG performance status 0 - 2.

- Age ≥ 18 years.

- Able to provide informed consent.

- Patients at reproductive potential must agree to practice an effective contraceptive
method. Women of childbearing potential must not be pregnant or lactating.

Exclusion Criteria:

- Previous radiotherapy to the intended treatment site that precludes developing a
treatment plan that respects normal tissue tolerances.

- Serious medical co-morbidities precluding radiotherapy.

- Pregnant or lactating women.

- Target lesion(s) is/are complicated bone metastases that include clinical or
radiological evidence of spinal cord compression or impending pathological fracture.

- Leptomeningeal disease.

- Malignant pleural effusion.

- Absolute neutrophil count (ANC) <1.0 K/mcL and platelet count <50 K/mcL at time of
enrollment.

- Patients whose entry to the trial will cause unacceptable clinical delays in their
planned management.