NCT04068649

Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer

A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Neoplasm

Interventions

Type	Name	Description
RADIATION	Palliative Radiation Therapy	Undergo palliative RT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2019-11-18
• Primary completion: 2027-11-18
• Completion: 2027-11-18
• First posted: 2019-08-28
• Last updated: 2025-04-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study