Recruiting
Phase 2

Stereotactic Radiosurgery

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT04218617

Conditions

Spine Metastases

Spine Stereotactic Radiosurgery (sSRS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diagnostic MRI

Planning MRI

Simulation CT

QOL assessment

Brief pain inventory (BPI)

Study Details

Brief 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.

Conditions

Spine Metastases

Spine Stereotactic Radiosurgery (sSRS)

Study ID

NCT04218617

Start date

Feb 7, 2020

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Single fraction

sSRS 18 Gy in 1 fraction

active comparator: Arm 2 - Two fraction

sSRS 24 Gy in 2 fractions

Interventions

Diagnostic MRI

Diagnostic MRI

Planning MRI

Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)

Simulation CT

Simulation CT is obtained (1.5 mm slice thickness)

QOL assessment

QOL assessment

Brief pain inventory (BPI)

Brief pain inventory (BPI), including narcotic assessment

sSRS in 1 fraction

sSRS 18 Gy in 1 fraction

sSRS in 2 fraction

sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.

Primary outcome measure

  • 6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS [ Time Frame: At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment) ]

Central Contacts and Locations

Central contacts

Samuel T Chao, MD

1-866-223-8100TaussigResearch@ccf.org

Ehsan Balagamwala, MD

1-866-223-8100balagae@ccf.org

Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Samuel T. Chao, MD

866-223-8100TaussigResearch@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • C79.40
  • C79.49
  • C79.51
  • C79.52

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.