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

NCT04218617 | Recruiting Phase 2 FDA Device

• 1 other identifier: CASE3319
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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)

Keywords

C79.40; C79.49; C79.51; C79.52

Outcome Measures

Primary Outcomes (1)

• 6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS

  6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS Each treated vertebra will be assessed individually for VCF during radiologic follow-up

  At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)

Secondary Outcomes (4)

• Local control (LC) as defined as absence of local progression of disease In the event of disease progression, all cases will be reviewed at the multi-disciplinary spine tumor board for a consensus recommendation

  At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)

• Pain control (PC) as assessed by the Brief Pain Inventory (BPI)

  At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)

• Quality of life (QOL) assessed by EORTC QLQ-C30 (with BM22)

  At baseline and for each subsequent follow-up MRI (at 1 month, 3 months, 6 months and 12 months after treatment)

• Toxicity as assessed by CTCAE V. 5.0

  At follow-up MRI (1 month, 3 months, 6 months and 12 months after treatment)

Study Arms (2)

Arm 1 - Single fraction

EXPERIMENTAL

sSRS 18 Gy in 1 fraction

Device: Diagnostic MRI; Device: Planning MRI; Other: Simulation CT; Other: QOL assessment; Other: Brief pain inventory (BPI); Radiation: sSRS in 1 fraction

Arm 2 - Two fraction

ACTIVE COMPARATOR

sSRS 24 Gy in 2 fractions

Device: Diagnostic MRI; Device: Planning MRI; Other: Simulation CT; Other: QOL assessment; Other: Brief pain inventory (BPI); Radiation: sSRS in 2 fraction

Interventions

Diagnostic MRI DEVICE

Diagnostic MRI

Arm 1 - Single fraction; Arm 2 - Two fraction

Planning MRI DEVICE

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

Arm 1 - Single fraction; Arm 2 - Two fraction

Simulation CT OTHER

Simulation CT is obtained (1.5 mm slice thickness)

Arm 1 - Single fraction; Arm 2 - Two fraction

QOL assessment OTHER

QOL assessment

Arm 1 - Single fraction; Arm 2 - Two fraction

Brief pain inventory (BPI) OTHER

Brief pain inventory (BPI), including narcotic assessment

Arm 1 - Single fraction; Arm 2 - Two fraction

sSRS in 1 fraction RADIATION

sSRS 18 Gy in 1 fraction

Arm 1 - Single fraction

sSRS in 2 fraction RADIATION

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

Arm 2 - Two fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Samuel Chao, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel T Chao, MD

CONTACT

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

Ehsan Balagamwala, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: February 7, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after last participant is enrolled. Data will be available for a total of 2 years
• Access Criteria: Investigators whose purposed use of the data has been approved by the Cleveland Clinic Independent Review Committee. Data will be provided for individual participant meta-analysis. All requests must be made in writing to Sam Chao, MD (Chaos@ccf.org) or Ehsan Balagamwala (Balagae@ccf.org).

Locations

US (1)