Stereotactic Radiosurgery (SRS) for Spine Metastases

Not Applicable

Terminated

Brief Summary: This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy (defined as 18 Gy).

Detailed Description: This study will evaluate the pain control and the quality of life of patients with spinal metastases using stereotactic radiotherapy. Stereotactic radiotherapy is referred to as "targeted therapy". It uses special equipment to position the patient and guide the focused beams of radiation toward the cancer and away from normal surrounding tissue. This higher dose technique may work better to kill cancer cells with fewer side effects than standard radiation therapy.

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent.
Age greater than or equal to 18 years old.
Prior histologically-proven, non-hematogenous malignancy (Specific exclusions are multiple myeloma and lymphoma).
Radiographic evidence of one or two non-contiguous spinal metastases amenable to SRS.
Metastatic disease must be symptomatic (causing either pain or neurologic symptoms).
Maximum tumor size less than or equal to 5 cm.
Zubrod performance status of less than or equal to 3.
Life expectancy of greater than or equal to 3 months.
Women/Men of childbearing potential must use effective contraception.

Exclusion Criteria

No prior radiation delivered to the involved area
No evidence of spinal instability requiring urgent surgical intervention.
No evidence of spinal cord compression requiring emergent surgical or radiotherapeutic intervention.
No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) while on this protocol except at disease progression.Concomitant is defined as within 3 days before or after radiosurgery.
No pregnant or lactating women.
No active systemic infection.
No evidence of myelopathy or cauda equina syndrome on clinical evaluation

Arm && Interventions

Group	Intervention	Description
2	Stereotactic Radiosurgery	High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1	Stereotactic Radiosurgery	Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy

Primary Outcome Measures

Name	Time	Method
Musculoskeletal Function as Measured by the Oswestry Disability Index	6 months after completion of treatment	The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.
Quality of Life as Measured by the FACT-CNS Questionnaire	6 months after completion of treatment	The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.
Pain Control Rate as Measured by the The Brief Pain Inventory	6 months after completion of treatment	The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.

Secondary Outcome Measures

Name	Time	Method
Local Control Rate	6 months after end of treatment	Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.