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Brief Title: Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer
Official Title: A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)
Study ID: NCT04068649
Brief Summary: This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). 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.
Detailed Description: PRIMARY OBJECTIVES: I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease. SECONDARY OBJECTIVES: I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy. EXPLORATORY OBJECTIVES: I. Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer. IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes. V. Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician. ARM II: Patients undergo single fraction SBRT. After completion of study treatment, patients may be followed up at 5 and 12 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
The Cancer Institute at St. Francis Hospital, East Hills, New York, United States
Good Samaritan Hospital, West Islip, New York, United States
Name: Anurag K Singh
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR