Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
The purpose of this study is to determine if Conformal High Dose Intensity Modulated
 Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal
 column. This study involves patients who have been diagnosed with metastatic cancer to the
 thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the
 area of concern. The goal is to prove that this is not only a safe form of treatment, but
 that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer
 coming back in the area that the investigators treat which may reduce the risk of developing
 symptoms like pain in the future.
Inclusion Criteria:

 -  Histological confirmation of malignancy (non-small cell lung cancer, breast cancer
 (hormone refractory), prostate cancer (hormone refractory), lymphoma, renal cell
 carcinoma, myeloma by either biopsy or cytology of the primary or metastatic lesion.

 -  Patients must have radiological documentation of metastatic disease to the thoracic or
 lumbar spine including both positron emitted tomography (PET) or nuclear medicine bone
 scan (NMBS) and Magnetic Resonance Imaging (MRI) within 4 weeks prior to study entry.

 -  Patients with one to three spinal metastases to the thoracic or lumbar spine will be
 included.

 -  Spinal metastatic lesions should be limited to one vertebral body level or ≤ 6cm in
 greatest dimension.

 -  Tumors should not directly abut the spinal cord, and have at least 5mm separation from
 the spinal cord. For patients with tumors closer than 5mm, inclusion is permissible at
 the discretion of the treating radiation oncologist such that dosimetric review
 demonstrates that the total dose to spinal cord is within tolerable range of <10Gy to
 10% partial volume or max point dose 18 Gy.

 -  Patients must be able to fit into either the Elekta Stereotactic Body Frame or the
 Elekta Stereotactic BodyFix immobilization device.

 -  Must be ≥ 18 years of age.

 -  ECOG status 0-2.

 -  Women of childbearing potential and male participants must use an effective
 contraception method. (Until at least 60 days following treatment.)

 -  Negative urine pregnancy test within at least one week before starting treatment in
 women of child-bearing age.

 -  Patients must sign a study-specific informed consent form.

 Exclusion Criteria:

 -  Patients with evidence of spinal instability OR neurologic deficit resulting from bony
 compression of neurologic structures.

 -  Patients with other systemic illness, or have not recovered adequately from their
 primary treatment or who have evidence of progression of their current cancer prior to
 therapy that, in the investigator's opinion, would preclude their inclusion.

 -  Patient may not receive concomitant cytotoxic anti-neoplastic therapy during
 treatment. Patients may be allowed to use hormonal suppression therapy or
 bisphosphonates for hypercalcemia.

 -  Pregnant or lactating women.

 -  Any patient with symptoms of pain, compression fracture, neurologic deficit will not
 be included.

 -  Patients previously treated with radiation therapy to the thoracic or lumbar spinal
 levels of involved disease will not be included.