Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis
Condition: Metastatic Cancer; Pain
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the feasibility of successfully delivering image-guided radiosurgery or
           stereotactic body radiotherapy (SBRT) in patients with spine metastases in a cooperative
           group setting. (Phase II)

        -  Determine whether image-guided radiosurgery or SBRT (single dose of 16 Gy) improves pain
           control as measured by the 11-point Numerical Rating Pain Scale (NRPS) compared to
           conventional external beam radiotherapy (single dose of 8 Gy). (Phase III)

      Secondary

        -  Determine whether image-guided radiosurgery or SBRT improves the rapidity of pain
           response and increases the duration of pain response at the treated site(s) compared to
           conventional external beam radiotherapy, as measured by the NRPS. (Phase III)

        -  Compare adverse events associated with these treatment regimens, as measured by NCI
           CTCAE v3.0 criteria. (Phase III)

        -  Evaluate the long-term effects (24 months) of image-guided radiosurgery or SBRT on the
           vertebral bone (e.g., compression fracture) and the spinal cord, as measured by MRI.
           (Phase III)

      DETAILS:

      This is a multicenter, phase II study followed by a randomized phase III study. Patients
      enrolled in the phase III portion are stratified according to the number of spine metastases
      to be treated (1 vs 2-3) and the type of tumor (radioresistant [including soft tissue
      sarcomas, melanomas, and renal cell carcinomas] vs other).

      Phase II patients undergo MRI of the treated spine at baseline and at 3 months; phase III
      patients undergo MRI at baseline and at 3, 6, 12, and 24 months. Patients enrolled in the
      phase III portion also complete the Numerical Rating Pain Scale at baseline, at 1, 2, and 3
      weeks after randomization, and at 1, 3, 6, 12, and 24 months. Patients are followed after
      completion of study treatment.
    

Intervention name(s): External beam radiation therapy; Radiosurgery/SBRT
Intervention type(s): Radiation; Radiation
Intervention description(s): Single fraction dose of 8 Gy external beam radiation therapy; Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
Other intervention name(s): EBRT; stereotactic body radiotherapy; SRS; stereotactic radiosurgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal bone metastases; pain