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

Official Title

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Summary:

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumour may kill more tumour 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)

Trial Description

Primary Outcome:

  • Successful delivery of image-guided radiosurgery or stereotactic body radiation therapy in the Radiation Therapy Oncology Group (RTOG) cooperative group setting (Phase II)
  • Complete or partial pain response at the treated index site(s) at 3 months after study entry, as measured by the Numerical Rating Pain Scale (NRPS) (Phase III)
Secondary Outcome:
  • Rapidity of pain response, defined as time from study entry to complete or partial pain relief (Phase III)
  • Duration of pain response, defined as time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS) (Phase III)
  • Adverse events, as measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 criteria (Phase III)
  • Long-term effects (24 months) of treatment on the vertebral bone (e.g., compression fracture) and spinal cord (Phase III)
OBJECTIVES:
Primary
  • Determine the feasibility of successfully delivering image-guided radiosurgery or stereotactic body radiation therapy (SBRT) in patients with spine metastases in a cooperative group setting. (Phase II) (completed as of 8-30-11)
  • 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 radiation therapy (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 radiation therapy, 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)
OUTLINE:

This is a multicentre, phase II study (completed as of 8-30-11) 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 tumour (radioresistant [including soft tissue sarcomas, melanomas, and renal cell carcinomas] vs other).
  • Phase II: Patients undergo 1 high-dose image-guided radiosurgery or stereotactic body radiation therapy (SBRT) treatment over 60 minutes. (completed as of 8-30-11)
  • Phase III: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients undergo 1 high-dose image-guided radiosurgery or SBRT treatment over 60 minutes.
  • Arm II: Patients undergo 1 standard-dose external beam radiation therapy treatment over 5 minutes. Patients undergo MRI of the treated spine 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. NOTE: *Patients enrolled in the phase II portion undergo MRI at baseline and at 3 months. After completion of study treatment, patients are followed up periodically.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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