Trial Search Results

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

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. (phase II completed as of 8-30-11)

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborator: NRG Oncology


  • Radiation: external beam radiation therapy
  • Radiation: image-guided radiation therapy
  • Radiation: radiosurgery
  • Radiation: stereotactic body radiation therapy


Phase 2/Phase 3



   - Diagnosis of localized spine metastasis at the C1 to L5 levels by a screening imaging
   study (bone scan, PET, CT, or MRI), meeting any of the following criteria:

      - Solitary spine metastasis

      - Two contiguous spine levels involved

      - No more than 3 separate sites (e.g., C5, T5-6, and T12) involved

         - No more than 2 contiguous vertebral bodies involved at each separate site

      - Other visceral metastasis, and radioresistant tumors (including soft tissue
      sarcomas, melanomas, and renal cell carcinomas) are eligible

         - No myeloma or lymphoma

   - Epidural compression allowed provided there is ≥ 3 mm gap between the spinal cord and
   edge of epidural lesion

   - Paraspinal mass allowed provided it is ≤ 5 cm in the greatest dimension and contiguous
   with spine metastasis

   - Has undergone MRI of the involved spine within the past 4 weeks to determine the
   extent of spine involvement

   - No spine metastasis that is not planned to be treated per protocol

   - No rapid neurologic decline

      - Mild to moderate neurological signs, including 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), allowed

   - No spine instability due to compression fracture, frank spinal cord compression or
   displacement, or epidural compression within 3 mm of the spinal cord

   - No more than 50% loss of vertebral body height

   - No bony retropulsion causing neurologic abnormality


   - Zubrod performance status 0-2

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - Must be ambulatory

   - No medical contraindications to an MRI of the spine

   - No allergy to contrast dye used in MRI or CT scans

   - The patient must have a score on the Numerical Rating Pain Scale of ≥ 5 within 1 week
   prior to registration 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


   - Concurrent pain medication allowed

   - No prior radiotherapy to the index spine

   - No chemotherapy for ≥ 24 hours before, during, and for ≥ 24 hours after completion of

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting