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Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine

Phase 2
18 Years
Open (Enrolling)
Vertebral Metastasis

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Trial Information

Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to any skeletal related event

Outcome Description:

Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression.

Outcome Time Frame:

up to 24 months

Safety Issue:


Principal Investigator

Ronald McGarry, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky


United States: Institutional Review Board

Study ID:




Start Date:

December 2009

Completion Date:

December 2015

Related Keywords:

  • Vertebral Metastasis
  • Female Breast Cancer
  • Kidney Cancer
  • Lung Cancer
  • Prostate Cancer
  • Vertebral metastasis
  • Neoplasm Metastasis



University of Kentucky Lexington, Kentucky  40536-0098