This phase II trial studies how well hypofractionated stereotactic radiation therapy works in treating younger patients with sarcomas that have spread to other bony sites in the body. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01763970.
PRIMARY OBJECTIVES:
I. To determine the lesion-specific local control at 6 months of stereotactic body radiation therapy (SBRT) delivered to a dose of 4000 centigray (cGy) in 5 fractions of 800 cGy each for patients greater than 3 years of age and =< 40 years of age with metastatic disease of bone secondary to pediatric non-rhabdomyosarcoma soft tissue or bone sarcoma.
SECONDARY OBJECTIVES:
I. To describe the toxicity of SBRT delivered to a dose of 4000 cGy in 5 fractions of 800 cGy each for the population enrolled using grading with Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0.
II. To assess clinical response rate of each treated site by serial computed tomography (CT) assessment (fludeoxyglucose F 18 [FDG]-positron emission tomography [PET]/CT is optional for assessment).
III. To assess long-term clinical outcomes of this patient population after completion of SBRT by measuring relapse-free survival and overall survival.
IV. To assess quality of life following completion of SBRT using pre- and post-SBRT completion of the Brief Pain Inventory form and 10 point Visual Analog scale which will be filled out by the patient.
OUTLINE:
Patients undergo hypofractionated SBRT once daily for a total of 5 fractions. Treatment should be delivered as 5 consecutive days over 1 week, but may be delivered over 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then at 3, 6, 9, 12, 18, 24, 30, and 36 months.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMatthew Michael Ladra