This phase I/II trial studies how well palliative radiation therapy works in treating patients with solid tumors that have spread to other places in the body (metastatic) and with highest risk to spread to the bone (bone metastases). Early intervention with radiation to some bone metastases before they become painful may potentially prevent complications associated with bone metastases, such as fracture caused by the tumor in the bone, tumor displacing the spinal cord, and significant bone pain alleviated by palliative radiation or surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03523351.
PRIMARY OBJECTIVE:
I. To assess whether early palliative radiation of the highest risk asymptomatic or minimally symptomatic bone metastasis in patients with metastatic cancer can decrease the number of skeletal-related events (SREs), defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.
SECONDARY OBJECTIVES:
I. To compare the number of hospitalizations related to SREs between standard of care and upfront radiation therapy (RT) arms.
II. To compare pain-related quality of life of between standard of care and RT arms, using the Brief Pain Inventory (BPI) form.
III. To collect health care utilities in the standard of care and RT arms using the EuroQol Group European Quality of Life Five Dimension Five Level (EQ-5D-5L) form.
IV. To compare pain-free survival (PFS) and overall survival (OS) between RT and standard of care arms.
V. To evaluate Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 toxicity events in the upfront RT arms.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients continue their current therapy or are transitioned to a new standard of care therapy at the discretion of the treating oncologist. Patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development.
ARM II: Patients undergo selective RT to 5 or less high risk bone metastases. Patients may undergo systemic therapy concurrently with RT at the discretion of treating radiation oncologist and medical oncologist.
After completion of study treatment, patients are followed up at 3, 6, and 12 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDivya Yerramilli
