NCT02527304

Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT uses information gathered during treatment to inform, guide, and alter future radiation treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment. SECONDARY OBJECTIVES: I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment. II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment. III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment. OUTLINE: Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. After completion of study treatment, patients are followed up periodically.

Conditions

• Melanoma
• Metastatic Malignant Neoplasm in the Spine
• Renal Cell Carcinoma
• Soft Tissue Sarcoma
• Spinal Cord Compression

Interventions

Type	Name	Description
RADIATION	Image-Guided Adaptive Radiation Therapy	Undergo adaptive staged SBRT
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Stereotactic Body Radiation Therapy	Undergo adaptive staged SBRT

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-08-19
• Last updated: 2024-03-06
• Results posted: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study