RECRUITING

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

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Conditions

Spine MetastasesSpine Stereotactic Radiosurgery (sSRS)C79.40C79.49C79.51C79.52

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-07
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04218617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Karnofsky Performance Status (KPS) ≥ 70
  2. * 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)
  3. * Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI.
  4. * 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.
  5. * Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
  6. * Patients with epidural disease are permitted so long as there is no cord compression.
  7. * Paraspinal extension is permitted, so long as the paraspinal component is ≤5 cm
  8. * 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
  9. * History and physical within four weeks of registration.
  10. * Negative pregnancy test within four weeks of registration for women of childbearing potential.
  11. * Diagnostic spine MRI with and without contrast within four weeks of registration
  12. * 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
  13. * Patients may have prior EBRT at the index site.
  14. * Informed consent of the participant.
  1. * Lesions at C1-2 or S1-Coccyx.
  2. * Hematologic malignancies including lymphoma and myeloma.
  3. * Multiple primary cancers.
  4. * Primary neoplasms of the spine
  5. * Prior corpectomy, kyphoplasty/vertebroplasty, or instrumentation at the site of planned sSRS.
  6. * Spinal cord compression.
  7. * Paraspinal mass \>5 cm.
  8. * Patients with rapid neurologic decline.
  9. * Bony retropulsion resulting in neurologic deficit.
  10. * Patients with contraindications to MRI.
  11. * Patients allergic to intravenous contrast for MRI or CT.
  12. * Patients with emergent spinal cord compression.
  13. * Patients with mechanical instability of the spine.
  14. * Patients with active connective tissue disease.
  15. * Patients who previously underwent sSRS to the vertebrae of interest.
  16. * Patients with diffuse or multilevel metastatic spinal disease with \>20% involvement of vertebral bodies, defined as involvement of \>5 vertebral levels.
  17. * Inability to participate in study activities due to physical or mental limitations.
  18. * Inability or unwillingness to return for all required follow-up visits and imaging.
  19. * Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.

Contacts and Locations

Study Contact

Samuel T Chao, MD
CONTACT
1-866-223-8100
TaussigResearch@ccf.org
Ehsan Balagamwala, MD
CONTACT
1-866-223-8100
balagae@ccf.org

Principal Investigator

Samuel Chao, MD
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Samuel Chao, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-07
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2020-02-07
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Spine Metastases
  • Spine Stereotactic Radiosurgery (sSRS)