Localized Spine Metastasis 0631

May 09, 2017

Sponsor: Radiation Therapy Oncology Group

Number: 0631

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely) 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. Metastasis is the development of secondary malignant growths at a distance from a primary site of cancer.

Who’s eligible:

  • The patient must have a 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 radio resistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible - No myeloma or lymphoma
  • Epidural compression (metastatic tumor grows into the epidural space) is allowed provided there is ≥ 3 mm gap between the spinal cord and edge of epidural lesion. The patient must have undergone an MRI of the involved spine within the past 4 weeks to determine the extent of spine involvement.
  • This study is for patients age 18 and older.

Available at: The Hospital of Central Connecticut.

Cancer Clinical Research Office