Comparing single and double sessions of spine radiosurgery for vertebral metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness and safety of single-fraction versus two-fraction spine stereotactic radiosurgery (sSRS) for treating vertebral metastases. Participants will be randomly assigned to receive either one or two treatment sessions, with the primary goal of determining which approach results in fewer vertebral compression fractures after six months. Additional objectives include assessing local control, pain management, quality of life, and potential side effects over a 12-month period. The study will enroll approximately 130 participants, with 65 in each treatment group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Karnofsky Performance Status (KPS) ≥ 70
* RPA class 1 (KPS \>70 AND controlled systemic disease) or RPA Class 2 (KPS \>70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)
* Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
* Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.
* Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
* Patients with epidural disease are permitted so long as there is no cord compression.
* Paraspinal extension is permitted, so long as the paraspinal component is ≤5 cm
* Multiple small metastatic lesions (\<20% vertebral body involvement) of no clinical correlate are permitted, and not included in the irradiated segments as per RTOG 0631
* History and physical within four weeks of registration.
* Negative pregnancy test within four weeks of registration for women of childbearing potential.
* Diagnostic spine MRI with and without contrast within four weeks of registration
* Neurological exam within four weeks of registration to rule out rapid neurological decline. Mild to moderate neurological deficits are acceptable, as long as distance between lesion and spinal cord is ≥3 mm
* Patients may have prior EBRT at the index site.
* Informed consent of the participant.

Exclusion Criteria:

* Lesions at C1-2 or S1-Coccyx.
* Hematologic malignancies including lymphoma and myeloma.
* Multiple primary cancers.
* Primary neoplasms of the spine
* Prior corpectomy, kyphoplasty/vertebroplasty, or instrumentation at the site of planned sSRS.
* Spinal cord compression.
* Paraspinal mass \>5 cm.
* Patients with rapid neurologic decline.
* Bony retropulsion resulting in neurologic deficit.
* Patients with contraindications to MRI.
* Patients allergic to intravenous contrast for MRI or CT.
* Patients with emergent spinal cord compression.
* Patients with mechanical instability of the spine.
* Patients with active connective tissue disease.
* Patients who previously underwent sSRS to the vertebrae of interest.
* Patients with diffuse or multilevel metastatic spinal disease with \>20% involvement of vertebral bodies, defined as involvement of \>5 vertebral levels.
* Inability to participate in study activities due to physical or mental limitations.
* Inability or unwillingness to return for all required follow-up visits and imaging.
* Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.

Where it's running

• Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Samuel Chao, MD — Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
• Study coordinator: Samuel T Chao, MD
• Email: TaussigResearch@ccf.org
• Phone: 1-866-223-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.