Radiotherapy for Solid Tumor Spine Metastases
Condition: Solid Tumor Spine Metastases
MeSH terms: Neoplasm Metastasis
Intervention: Post-operative, Stereotactic Body Radiation Therapy (SBRT)
Intervention description: All participants received SBRT at 600 cGy x 5 fractions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Post-Operative Stereotactic Radiosurgery
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 12 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: stereotactic radiotherapy; SRS

Summary:

      Although it is being increasingly used off protocol, there is minimal data regarding the
      efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of
      metastatic lesions to the spine. The primary objective of this study is to evaluate
      radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared
      to the expected rate following conventional radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥12 years

          -  Histologically proven solid tumor malignancy with metastasis to the spine. Diagnosis
             may be acquired from needle biopsy, cytology, or surgical biopsy or resection.

          -  Radiographic evidence of spinal metastasis is required and may be obtained from plain
             radiographs, radionuclide bone scans, computed tomography imaging, and magnetic
             resonance imaging. Other studies may be used with principal investigator approval.

          -  The patient must have undergone surgical resection resection (gross total, subtotal,
             or biopsy) of the spinal lesion(s) no more than 12 weeks prior to SRS treatment.

          -  Treating physician must deem that SRS is appropriate treatment for the metastatic
             spinal lesion(s).

          -  Each SRS target must be the equivalent of ≤3 vertebral levels

          -  The patient must have a Karnofsky Performance Score of 40 or greater

          -  If a woman is of child-bearing potential, a negative urine or serum pregnancy test
             must be demonstrated prior to treatment. Women of childbearing potential and men must
             agree to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) for the duration of study participation and for up to 12 weeks following
             the study. Should a woman become pregnant or suspect she is pregnant while
             participating in this study she should inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Prior radiation or radiosurgery to the involved level of the spine

          -  Spine disease from leukemia, lymphoma or myeloma

          -  No prior malignancy is allowed except for adequately treated basal cell or squamous
             cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient
             has been disease free for at least 1 year.

          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements will be excluded.

          -  Pregnant and breastfeeding women are excluded. Women of child-bearing potential who
             are unwilling or unable to use and acceptable method of birth control to avoid
             pregnancy for the entire study period and up to 12 weeks after the study are excluded.
             Male subjects must also agree to use effective contraception for the same period as
             above.