Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis

Pain Clinical Trial

Official title:

Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855803
• Other study ID #: STU 072010-134
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: January 20, 2021

Study information

• Verified date: February 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• radiation
Given in 1 or 5 fractions

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Response as Measured by VAS at 3 Months	Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months; Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response	3 month
Secondary	Pain Response	Duration of pain response as measured by VAS at 1 month; Patient pain was recorded on a 10-point scale (0: no pain, 10: most severe pain). At baseline patients were required to have a pain score of 4 or higher associated with spine metastases. Pain response was recorded again during follow-up visits to determine the pain response: A pain score of 0 represents a complete response A decrease in the pain score by at least 2 points represents a partial response VAS scores were used to determine the number of patients with a partial pain response, with a complete pain response, and without a pain response	1 month
Secondary	Overall Survival	Overall survival measured from the date of accession to the date of death. Median times will be reported.	5 year
Secondary	Daily Function	Time to functional decline as measure by the Brief Pain Inventory (BPI) at baseline. BPI has two sections that are scored- pain severity and pain interference. For each of these a numeric scale from 0-10 is used, with 0 being the worst pain and 10 being the worst pain.	Baseline
Secondary	Quality of Life Questionnaire Responses	Number of participants who filled out the Functional Assessment of Cancer Therapy- General (FACT-G) and the European Quality of Life Five Dimension (EQ-5D) questionnaires at baseline, 1, 3, 6, and 12 months	12 months