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Phase 2
Age: 18Years +
All Genders
ID04218617

Comparing One-Session Versus Two-Session Spine Radiosurgery for Vertebral Metastases to Reduce Fracture Risk

Led by Case Comprehensive Cancer Center · Updated on 2026-08-06

130

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating spine stereotactic radiosurgery sSRS for treating vertebral metastases. The study aims to compare the effects of delivering sSRS in one high-dose treatment versus two high-dose treatments. The main goal is to determine which approach reduces the risk of vertebral compression fractures, a common side effect of spine radiosurgery that may cause pain or neurological symptoms. Participants will be randomly assigned to one of two groups one receiving a single 18 Gy dose of sSRS in one session, and the other receiving a total of 24 Gy divided into two sessions delivered either on consecutive days or one day apart. The study also evaluates local tumor control, pain relief, quality of life, and treatment-related side effects such as pain flare and radiation effects on tissues at multiple time points up to 12 months. During the study, participants will undergo diagnostic and planning MRIs, simulation CT scans, and assessments of pain and quality of life. Follow-up MRIs will be done at 1, 3, 6, and 12 months after treatment to monitor vertebral compression fractures and tumor progression. Researchers will also assess toxicity using standard criteria. Overall participation lasts up to one year with regular imaging and questionnaire evaluations to track outcomes and safety.

CONDITIONS

Brief Title

Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases

Research Team

S

Samuel T Chao, MD

E

Ehsan Balagamwala, MD

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