AzTrials
AzTrials

Spine MetastasesPhase 2NCT04218617

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

A Phase 2 study testing Diagnostic MRI, Planning MRI and Simulation CT in people with Spine Metastases and Spine Stereotactic Radiosurgery (sSRS), run by Case Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Diagnostic MRI, Planning MRI and Simulation CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUnited States
Study dates
7 Feb 2020to Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Samuel T Chao, MD contact

1-866-223-8100

TaussigResearch@ccf.org

Ehsan Balagamwala, MD contact

1-866-223-8100

balagae@ccf.org

United States1 site, 1 recruiting

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

    Samuel T. Chao, MD, 866-223-8100, TaussigResearch@ccf.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed 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.
Being tested
Diagnostic MRI, Planning MRI, Simulation CT, QOL assessment, Brief pain inventory (BPI)
Keywords
C79.40, C79.49, C79.51, C79.52

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic MRIDevice

    Diagnostic MRI

  • Planning MRIDevice

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

  • Simulation CTOther

    Simulation CT is obtained (1.5 mm slice thickness)

  • QOL assessmentOther

    QOL assessment

  • Brief pain inventory (BPI)Other

    Brief pain inventory (BPI), including narcotic assessment

  • sSRS in 1 fractionRadiation

    sSRS 18 Gy in 1 fraction

  • sSRS in 2 fractionRadiation

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

Study groups in NCT04218617
Study groupRoleWhat they receive
Arm 1 - Single fractionExperimentalsSRS 18 Gy in 1 fraction
Receives: 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 fractionActive comparatorsSRS 24 Gy in 2 fractions
Receives: Device: Diagnostic MRI; Device: Planning MRI; Other: Simulation CT; Other: QOL assessment; Other: Brief pain inventory (BPI); Radiation: sSRS in 2 fraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. 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

    LC as defined as absence of local progression of disease, which include the following:

    1. Gross unequivocal increase in tumor volume or linear dimension.
    2. Any new or progressive tumor within the epidural space.
    3. Neurologic deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions on MRI.

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

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

    PC at each treated vertebral level assessed by the BPI [9 item questionnaire (range: 0-10), higher scores = worse pain], then defined by RTOG 0631 as follows:

    Complete relief (CR): Pain score of 0 at index site 3 mo post-treatment. CR is requisite of no increase in narcotic analgesics.

    Partial relief (PR): Reduction in BPI of ≥ 3 points at index site, provided other treated lesions have increased in pain score and participant did not require increase in narcotic analgesics for site of interest. Participants needing increase in narcotics for site will not be scored as having PR. Those needing increase in narcotics for a distant site will remain eligible for CR/PR.

    Stable response (SR): Post-treatment pain score same as or within 2 points of baseline score at index site with no increase in narcotic analgesics for site of interest.

    Progressive pain: Post-treatment increase of at least 3 points from baseline pain score at index site or increase in narcotics for site of interest.

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

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

    Quality of life as measured by (EORTC QOL-C30) - 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")

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

  4. Toxicity as assessed by CTCAE V. 5.0

    Toxicity as assessed by criteria in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Rates of grade 1-5 toxicities will be reported

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2020
  2. Study start7 Feb 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04218617
Sponsor's protocol ID
CASE3319
Status last verified
Aug 2026
First submitted
2 Jan 2020
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All IPD that underlie results in publication, after de-identification

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diagnostic MRI, Planning MRI and Simulation CT in people with Spine Metastases and Spine Stereotactic Radiosurgery (sSRS), run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samuel T Chao, MD (1-866-223-8100, TaussigResearch@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in