Clinical trial NCT00593320: Stereotactic Radiosurgery (SRS) for Spine Metastases
Official title: Stereotactic Radiosurgery (SRS) for One or Two Localized Spine Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Metastases
Keywords: SRS
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Control Rate as Measured by the The Brief Pain Inventory
timeFrame: 6 months after completion of treatment
measure: Musculoskeletal Function as Measured by the Oswestry Disability Index
timeFrame: 6 months after completion of treatment
measure: Quality of Life as Measured by the FACT-CNS Questionnaire
timeFrame: 6 months after completion of treatment
Secondary outcomes:
measure: Local Control Rate
timeFrame: 6 months after end of treatment
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeffrey Bradley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: