Clinical trial NCT00855803: Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Official title: Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: spinal cord metastases
unspecified adult solid tumor, protocol specific
pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis.

PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.

Detailed description: OBJECTIVES:

Primary

* To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis.

Secondary

* To determine the duration of pain response at the treated site(s) scored as the time of maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.
* To determine the functional preservation of improvement as measured by the Brief Pain Inventory.
* To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.
* To determine the long-term stability of the treated vertebral bone (e.g., fracture, sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan, and plain radiographs.

OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to the planned treatment site(s).

* Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each.
* Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90 minutes.

Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty.

Patients complete pain and quality-of-life questionnaires at baseline and periodically during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and then every 6 months for 3 years to assess changes in vertebral bone strength and stability.

After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months, and then every 6 months for 3 years.

Eligibility criteria: Eligibility:

Inclusion:

* Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
* Patients must have a VAS of ≥4 at any of the planned treatment sites
* Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
* Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
* Narcotic pain prescription and usage information must be available and documented
* Patients must sign study specific consent
* Above the age of 18
* For women of childbearing age a negative pregnancy test is required
* Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
* Zubrod score of 0-2

Exclusion:

* Patients who have been non-ambulatory for more than 7 days
* Patients with compression fractures
* Spine instability requiring fixation
* Patients with paraspinal extension
* Patients with bony fragments
* Planned systemic treatment within one week after treatment.
* Absence of pathological diagnosis of cancer
* Chemotherapy within one week of treatment
* Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
* Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Patient had a transmural myocardial infarction within the last 6 months
* Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
* PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
* Platelet count is \< 50,000
* History of significant psychiatric illness

Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring

Primary outcomes:
measure: Pain Response as Measured by VAS at 3 Months
timeFrame: 3 month
Secondary outcomes:
measure: Pain Response
timeFrame: 1 month
measure: Overall Survival
timeFrame: 5 year
measure: Daily Function
timeFrame: Baseline
measure: Quality of Life Questionnaire Responses
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: