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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00855803
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 143.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific	Radiation: radiation	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 20, 2021
• Actual Study Completion Date: Jan 20, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Radiation followed by Vertebroplasty Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*. *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.

Radiation: radiation; Given in 1 or 5 fractions; Other Names: stereotactic body radiation therapy

Outcome Measures

Primary Outcome Measures

1. Pain Response as Measured by VAS at 3 Months [3 month]

   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

Secondary Outcome Measures

1. Pain Response [1 month]

   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

2. Overall Survival [5 year]

   Overall survival measured from the date of accession to the date of death. Median times will be reported.

3. Daily Function [Baseline]

   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.

4. Quality of Life Questionnaire Responses [12 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Robert D. Timmerman, MD, Simmons Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 26, 2017

More Information

Publications

None provided.

• Responsible Party: Robert Timmerman, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT00855803
• Other Study ID Numbers: STU 072010-134
• First Posted: Mar 4, 2009
• Last Update Posted: Mar 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Robert Timmerman, Professor, University of Texas Southwestern Medical Center: spinal cord metastases; unspecified adult solid tumor, protocol specific; pain
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

Participant Flow

Recruitment Details	3 withdrew before starting treatment, 1 had clinical decline prior to treatment and was removed, 1 was removed prior to treatment for local progression, and 1 was removed due to a pre-existing compression fracture prior to treatment, These 6 patients did start the study but were assessed for other outcomes.

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Period Title: Overall Study
STARTED	35
COMPLETED	21
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Overall Participants	35
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	16 45.7%
Male	19 54.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 20%
White	27 77.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Primary Site (participants) [Number]
Lung	10 28.6%
Breast	4 11.4%
Prostate	4 11.4%
Kidney	4 11.4%
Melanoma	3 8.6%
Colorectal	2 5.7%
Oropharyngeal	1 2.9%
Thyroid	1 2.9%
Spine Location (participants) [Number]
Cervical	4 11.4%
Thoracic	12 34.3%
Lumbar	13 37.1%
Number of vertebrae treated (participants) [Number]
1	23 65.7%
2	6 17.1%
Preexisting endplate fracture (participants) [Number]
Yes	5 14.3%
No	24 68.6%

Outcome Measures

1. Primary Outcome

Title	Pain Response as Measured by VAS at 3 Months
Description	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
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

Patients who were evaluable at the 3-month timepoint

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Measure Participants	21
Patients with a partial pain response at 3 months	8 22.9%
Patients with a complete pain response at 3 months	12 34.3%
Patients without a pain response	1 2.9%

2. Secondary Outcome

Title	Pain Response
Description	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
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

Patients who were evaluable at the 1 month timepoint

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Measure Participants	25
Patients with a complete pain response	10 28.6%
Patients with a partial pain response	10 28.6%
Patients with no pain response	5 14.3%

3. Secondary Outcome

Title	Overall Survival
Description	Overall survival measured from the date of accession to the date of death. Median times will be reported.
Time Frame	5 year

Outcome Measure Data

Analysis Population Description

Patients who received spine SABR

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Measure Participants	29
Median (Full Range) [months]	9

4. Secondary Outcome

Title	Daily Function
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Patients enrolled to the study

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Measure Participants	35
Pain Severity	5.8 (1.8)
Pain Interference	6.0 (2.2)

5. Secondary Outcome

Title	Quality of Life Questionnaire Responses
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Enrolled participants

Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
Measure Participants	35
Number of responses at baseline	35
Number of responses at 1 month	29
Number of responses at 3 months	21
Number of responses at 6 months	16
Number of responses at 12 months	7

Adverse Events

Time Frame	5 years
Arm/Group Title	Total Population
Arm/Group Description	All patients enrolled to the study
All Cause Mortality
	Total Population
	Affected / at Risk (%)	# Events
Total	2/29 (6.9%)
Serious Adverse Events
	Total Population
	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)
Nervous system disorders
Acute myelopathy	1/29 (3.4%)	1
Other (Not Including Serious) Adverse Events
	Total Population
	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)
Gastrointestinal disorders
Esophagitis	1/29 (3.4%)	1
Injury, poisoning and procedural complications
Acute hematoma	1/29 (3.4%)	1
Nervous system disorders
Spinal canal stenosis	1/29 (3.4%)	1
Renal and urinary disorders
Urinary retention	1/29 (3.4%)	1
Metastatic renal cell carcinoma	1/29 (3.4%)	1
Surgical and medical procedures
Laminectomy	1/29 (3.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.