Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Locali… (NCT00922974) | Clinical Trial Compass
CompletedPhase 2/3
Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis
United States399 participantsStarted 2009-11
Plain-language summary
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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Inclusion criteria
✓. 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).
✓. 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.
✓
What they're measuring
1
Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II)
Timeframe: The day of protocol treatment
2
Percentage of Patients With Complete or Partial Pain Response at 3 Months (Phase III)
. 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.
Exclusion criteria
✕. 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;