Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Condition: Primary Tumor; Metastatic Cancer
MeSH terms: Neoplasm Metastasis
Intervention: Radiosurgery/SBRT; External Beam Radiation Therapy
Intervention description: 1, 3 or 5 SBRT treatments; 10 consecutive days of standard radiation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how effective SBRT is compared to traditional
      radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is
      delivered at a higher dose for a shorter period of time when compared to standard radiation
      therapy and the aim is to see if there will be an improvement both in pain control and your
      cancer It is not known whether SBRT is better or worse than current standard therapy. If you
      are selected to receive the experimental treatment in this research study, SBRT uses highly
      focused x-rays that deliver a single high dose to a specific area of the spine compared to
      conventional standard radiation over a period of 10 days which has been the standard proven
      treatment to help your condition. The investigators will also determine which treatment
      provides the most rapid pain relief with the least side effects. It is possible that SBRT may
      not be better or could be more toxic. The investigators will conduct quality of life
      assessments and pain scale index to assess how you are feeling once you have had the
      intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed primary tumor or metastatic cancer with radiological
             diagnosis of spine metastasis

          -  The patient must have localized spine metastasis from the C1 to L5 levels by a
             screening imaging study

          -  Zubrod Performance Status 0-2

          -  History/physical examination within 2 weeks prior to registration

          -  Negative 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 contraception (hormonal or barrier method of birth
             control; abstinence) prior to study entry and for the duration of study participation.

          -  MRI of the involved spine within 4 weeks prior to registration to determine the extent
             of the spine involvement

          -  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. Patients taking medication for pain at the time of registration are
             eligible.

          -  Neurological examination within 1 week prior to registration to rule out rapid
             neurologic decline

        Exclusion Criteria:

          -  Histology of myeloma, lymphoma or germ cell tumors.

          -  Non-ambulatory patients

          -  Spine instability due to a compression fracture

          -  > 50% loss of vertebral body height

          -  Frank spinal cord displacement or epidural involvement with> 25% encirclement of cord
             or >25% spinal canal involvement.

          -  Prior radiation to the index spine

          -  Patients for whom an MRI of the spine is medically contraindicated

          -  Uncontrolled intercurrent illness