Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis

Completed · Phase 2/Phase 3

Conditions studied: Metastatic Cancer, Pain

In brief

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This randomized phase II/III trial is studying how well image-guided radiosurgery or stereotactic body radiation therapy works and compares it to external-beam radiation therapy in treating patients with localized spine metastasis.

Key facts

Study ID

NCT00922974

Run by

Radiation Therapy Oncology Group

People needed

399

Starts

2009-11-01

Expected to finish

2020-04-06

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study [bone scan, positron emission tomography (PET), computerized tomography (CT), or magnetic resonance imaging (MRI)] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites [e.g., C5, T5-6, and T12] are permitted.) Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible. See Figure 1 in Section 3.1.1. of the protocol for a depiction of eligible metastatic lesions: 1) a solitary spine metastasis; 2) two contiguous spine levels involved; or 3) a maximum of 3 separate sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. Epidural compression (arrow) is eligible when there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion (see #10). A paraspinal mass ≤ 5 cm is allowed (see #11).
• There can be multiple small metastatic lesions shown in other vertebral bodies as shown in referenced diagram. The metastatic lesion of each spine should be less than 20% of the vertebral body as opposed to the diffuse vertebral involvement. These small lesions are often seen in the MRI even when bone scan or PET was negative. Most of these lesions are not clinically required to be treated and are therefore not included in the target volume of this protocol. Only the painful spine (pain score≥ 5) is to be treated .
• Zubrod Performance Status 0-2;
• Age ≥ 18;
• History/physical examination within 2 weeks prior to registration;
• Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential;
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
• MRI (contrast is not required but strongly recommended) of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement; an MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. Note: If an MRI was done as a screening imaging study for eligibility (see Section -1), the MRI can be used as the required MRI for treatment planning.
• Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for spine radiosurgery. Documentation of the patient's initial pain score is required. Patients taking medication for pain at the time of registration are eligible.
• Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see Appendix III for the standardized neurological examination. Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
• Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion.
• Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
• Patients must provide study specific informed consent prior to study entry.

You may not qualify if…

• Histologies of myeloma or lymphoma;
• Non-ambulatory patients;
• Spine instability due to a compression fracture;
• > 50% loss of vertebral body height;
• Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord;
• Patients with rapid neurologic decline;
• Bony retropulsion causing neurologic abnormality;
• Prior radiation to the index spine;
• Patients for whom an MRI of the spine is medically contraindicated;
• Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye.

Where it is running

• University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus — New Britain, Connecticut, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Cancer Center at Ball Memorial Hospital — Muncie, Indiana, United States
• Lucille P. Markey Cancer Center at University of Kentucky — Lexington, Kentucky, United States
• James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
• St. Agnes Hospital Cancer Center — Baltimore, Maryland, United States
• Josephine Ford Cancer Center at Henry Ford Hospital — Detroit, Michigan, United States
• Butterworth Hospital at Spectrum Health — Grand Rapids, Michigan, United States
• William Beaumont Hospital - Royal Oak Campus — Royal Oak, Michigan, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• Billings Clinic - Downtown — Billings, Montana, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Payson Center for Cancer Care at Concord Hospital — Concord, New Hampshire, United States
• Seacoast Cancer Center at Wentworth - Douglass Hospital — Dover, New Hampshire, United States
• Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Capital Health Regional Cancer Center — Pennington, New Jersey, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States
• Summa Center for Cancer Care at Akron City Hospital — Akron, Ohio, United States
• Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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