Trial Outcomes & Findings for Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis (NCT NCT00855803)

Last Updated: 2022-03-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

3 month

Results posted on

2022-03-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Total Population All patients enrolled to the study
Overall Study STARTED	35
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Population All patients enrolled to the study
Overall Study Death	2
Overall Study Lost to Follow-up	2
Overall Study Technical inability to undergo procedure	2
Overall Study Not evaluable at 3 month timepoint	2
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	3

Baseline Characteristics

35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population n=35 Participants All patients enrolled to the study
Age, Continuous	60 years n=35 Participants
Sex: Female, Male Female	16 Participants n=35 Participants
Sex: Female, Male Male	19 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	7 Participants n=35 Participants
Race (NIH/OMB) White	27 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants
Primary Site Lung	10 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Breast	4 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Prostate	4 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Kidney	4 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Melanoma	3 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Colorectal	2 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Oropharyngeal	1 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Primary Site Thyroid	1 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Spine Location Cervical	4 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Spine Location Thoracic	12 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Spine Location Lumbar	13 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Number of vertebrae treated 1	23 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Number of vertebrae treated 2	6 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Preexisting endplate fracture Yes	5 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.
Preexisting endplate fracture No	24 participants n=29 Participants • 35 patients enrolled to the study, 29 patients started protocol treatment and had study specific measures completed.

PRIMARY outcome

Timeframe: 3 month

Population: Patients who were evaluable at the 3-month timepoint

Outcome measures

Outcome measures
Measure	Total Population n=21 Participants All patients enrolled to the study
Pain Response as Measured by VAS at 3 Months Patients with a complete pain response at 3 months	12 Participants
Pain Response as Measured by VAS at 3 Months Patients without a pain response	1 Participants
Pain Response as Measured by VAS at 3 Months Patients with a partial pain response at 3 months	8 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Patients who were evaluable at the 1 month timepoint

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

Outcome measures

Outcome measures
Measure	Total Population n=25 Participants All patients enrolled to the study
Pain Response Patients with a complete pain response	10 Participants
Pain Response Patients with a partial pain response	10 Participants
Pain Response Patients with no pain response	5 Participants

SECONDARY outcome

Timeframe: 5 year

Population: Patients who received spine SABR

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

Outcome measures

Outcome measures
Measure	Total Population n=29 Participants All patients enrolled to the study
Overall Survival	9 months Interval 0.0 to 63.4

SECONDARY outcome

Timeframe: Baseline

Population: Patients enrolled to the study

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.

Outcome measures

Outcome measures
Measure	Total Population n=35 Participants All patients enrolled to the study
Daily Function Pain Severity	5.8 score on a scale Standard Deviation 1.8
Daily Function Pain Interference	6.0 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 12 months

Population: Enrolled participants

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

Outcome measures

Outcome measures
Measure	Total Population n=35 Participants All patients enrolled to the study
Quality of Life Questionnaire Responses Number of responses at baseline	35 participant responses
Quality of Life Questionnaire Responses Number of responses at 1 month	29 participant responses
Quality of Life Questionnaire Responses Number of responses at 3 months	21 participant responses
Quality of Life Questionnaire Responses Number of responses at 6 months	16 participant responses
Quality of Life Questionnaire Responses Number of responses at 12 months	7 participant responses

Adverse Events

Total Population

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Total Population n=29 participants at risk All patients enrolled to the study
Nervous system disorders Acute myelopathy	3.4% 1/29 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	Total Population n=29 participants at risk All patients enrolled to the study
Gastrointestinal disorders Esophagitis	3.4% 1/29 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Acute hematoma	3.4% 1/29 • Number of events 1 • 5 years
Renal and urinary disorders Urinary retention	3.4% 1/29 • Number of events 1 • 5 years
Renal and urinary disorders Metastatic renal cell carcinoma	3.4% 1/29 • Number of events 1 • 5 years
Nervous system disorders Spinal canal stenosis	3.4% 1/29 • Number of events 1 • 5 years
Surgical and medical procedures Laminectomy	3.4% 1/29 • Number of events 1 • 5 years

Additional Information

Dr. Robert Timmerman

University of Texas Southwestern Medical Center

Phone: 214/645-7637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place