The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose.
The main questions it aims to answer are:
Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life?
Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes:
The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy.
Participants in this study will:
Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor.
Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI).
Complete questionnaires about their pain levels and quality of life during these visits.
Patients with a histologic diagnosis of non-hematopoietic malignancy
Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
Maximum four separate sites with a maximal involvement of two continuous vertebral levels
Patients do not have prior radiotherapy to the index spine(s)
Prior radiotherapy or radiosurgery to the index spine(s)
Serum creatinine > 2.0 mg/dL within 90 days prior registration
Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
Parallel
Spine Stereotactic Radiosurgery (SSRS)
RadiationA non-invasive procedure that uses highly focused, high-energy radiation beams to precisely target metastatic tumors in the spine. The procedure is delivered using advanced techniques like Intensity Modulated Radiotherapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT/RapidArc), which allow the radiation dose to conform tightly to the shape of the tumor. This approach maximizes the dose to the cancer while carefully sparing surrounding healthy tissues, especially the critical spinal cord. The entire course of treatment is delivered in a single session, guided by on-board imaging to ensure sub-millimeter accuracy.
Rate of Composite Treatment Failure at 12 Months
This is a composite endpoint that measures the percentage of participants in each arm who experience a treatment failure. A treatment failure is defined as the first occurrence of either of the following events: Clinically Significant Toxicity: The occurrence of a Grade 3 or higher adverse event that is definitely, probably, or possibly related to the radiation treatment. This includes specific neurological, musculoskeletal (e.g., spinal fracture), or gastrointestinal events as defined in the protocol. Local Tumor Progression: Unequivocal evidence of tumor growth at the treated spinal site, which is significant enough to warrant further medical intervention, such as spinal surgery or re-irradiation.
Health-Related Quality of Life (EORTC QLQ-C15-PAL)
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL), Taiwan version. This is a 15-item self-reported questionnaire assessing function and symptoms. Scores are converted to a 0-100 scale, with higher functional scores and lower symptom scores indicating better outcomes.
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National Taiwan University Hospital
Lead sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborator
National Taiwan University Hospital, Yun-Lin Branch
Collaborator
National Taiwan University
Collaborator
