A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases

Inclusion Criteria:

• Patients with pathologic diagnosis of solid primary malignancy with any radiographicreport of bone metastases including but not limited to plain x-ray, bone scan, CTscan, MRI, PET/CT scan, PSMA scan, PET fluciclovine scan. The exception is patientsdiagnosed with multiple myeloma are eligible.

• Patients with any pain or discomfort at proposed treatment site.

• Patients with life expectancy of 3 months or greater.

• Patients able to complete pain assessment and quality of life surveys.

• Patients with multiple osseous sites are eligible; however, should not treat morethan three separate isocenters concurrently. Additional isocenters can be treatedsequentially.

• Patients with prior surgery for osseous metastases are eligible.

• Patients age 18 years or older. Pediatric patients are usually enrolled on pediatricprotocols. There are no adverse data available for patients < 18 years of agetreated with SBRT, therefore children are excluded from this study.

• Patients may receive systemic therapy including chemotherapy, targeted therapy,immunotherapy, or other systemic agents up to and during radiation at treatingphysician's discretion per standard of care.

• Patients must have adequate organ and marrow function as defined below:

platelets ≥ 40,000/mcL

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial.

• The effects of radiation therapy on the developing human fetus are unknown. For thisreason and because radiation therapy as well as other therapeutic agents used inthis trial are known to be teratogenic, women of child-bearing potential and menmust agree to use adequate contraception (hormonal or barrier method of birthcontrol; abstinence) prior to study entry and for the duration of studyparticipation. (Refer to Pregnancy Assessment Policy MD Anderson InstitutionalPolicy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with anapplicable exclusionary factor which may be one of the following:

1. Postmenopausal (no menses in greater than or equal to 12 consecutive months)

2. History of hysterectomy or bilateral salpingo-oophorectomy.

3. Ovarian Failure (Follicle Stimulating Hormone and Estradiol in menopausalrange, who have received Whole Pelvic Radiation Therapy)

4. History of bilateral tubal ligation or another surgical sterilizationprocedure.

• Approved methods of birth control are as follows: Hormonal contraception (i.e. birthcontrol pills, injection, implant, transdermal patch, vaginal ring), Intrauterinedevice (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy,Implantable or injectable contraceptives, and condoms plus spermicide. Not engagingin sexual activity for the total duration of the trial and the drug washout periodis an acceptable practice; however periodic abstinence, the rhythm method, and thewithdrawal method are not acceptable methods of birth control. Should a woman becomepregnant or suspect she is pregnant while she or her partner is participating inthis study, she should inform her treating physician immediately.

• Men treated or enrolled on this protocol must also agree to use adequatecontraception prior to the study, for the duration of study participation, and 2weeks after completion of radiation therapy.

• Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion Criteria:

• Patients with prior radiation therapy to the proposed treatment site.

• Patient with current, un-treated cord compression at treatment site.

• Patients with a radiographic or pathologic fracture at the proposed treatment sitethat is not mechanically stable. If this is stabilized mechanically or seen byorthopedic surgery, this site is eligible for enrollment and treated on protocol

• Patients with metastases to hand and feet.

• Patients with previously treated with radioactive isotope (e.g. Sr 89) within 30days of randomization. This can have concomitant effects with radiation therapy.

• Patients with spinal metastases along cervical, thoracic, or lumbar spine are noteligible. However, if the primary site invades the paraspinal or spine region, theseare eligible.

• Pregnant patients are not eligible.