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

STATUS

Recruiting
participants needed

130
sponsor

Case Comprehensive Cancer Center

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Updated on 19 February 2024

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metastasis

sarcoma

x-rays

spinal cord

relieve pain

karnofsky performance status

stereotactic radiosurgery

bone scan

external beam radiation therapy

neurologic symptoms

compression fracture

soft tissue sarcomas

mri spine

melanoma

renal cell carcinoma

Summary

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue.

One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

Description

The primary objective of this study is to establish the non-inferiority in vertebral compression fracture (VCF) incidence at 6 months between single-fraction and two-fraction sSRS.

Other objectives are to to evaluate the 12-month impact of single- and two-fraction sSRS on local control (LC), pain control (PC), quality of life (QOL), and toxicity (specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis)

This study is planned as a two-arm randomized phase II trial to establish non-inferiority of single fraction sSRS compared to two-fraction sSRS. Approximately 130 participants will be enrolled in this trial; 65 participants in each arm:

Group 1: If you are assigned to this group, you will undergo spine radiosurgery in a single (1) session.
Group 2: If you are assigned to this group, you will undergo spine radiosurgery in two (2) sessions.

Details

Condition	Spine Metastases, Spine Stereotactic Radiosurgery (sSRS)
Age	18years - 100years
Treatment	Diagnostic MRI, Planning MRI, Simulation CT, QOL assessment, Brief pain inventory (BPI), sSRS in 1 fraction, sSRS in 2 fraction
Clinical Study Identifier	NCT04218617
Sponsor	Case Comprehensive Cancer Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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