Trial Outcomes & Findings for Stereotactic Radiosurgery (SRS) for Spine Metastases (NCT NCT00593320)
NCT ID: NCT00593320
Last Updated: 2015-03-04
Results Overview
The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.
TERMINATED
NA
2 participants
6 months after completion of treatment
2015-03-04
Participant Flow
The study opened to participant enrollment on 11/06/2007 and closed to participants enrollment on 03/26/2010.
Participant milestones
| Measure |
Arm 1: Low Dose
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
|
Arm 2: High Dose
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Radiosurgery (SRS) for Spine Metastases
Baseline characteristics by cohort
| Measure |
Arm 1: Low Dose
n=1 Participants
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
|
Arm 2: High Dose
n=1 Participants
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after completion of treatmentPopulation: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
The Brief Pain Inventory (BPI) is a 17 item patient self-rating scale assessing demographic data, use of medications, as well as sensory, and reactive components of pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months after completion of treatmentPopulation: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
The Oswestry Disability Index (ODI) has 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling), each of which contains 6 questions detailing the effect of pain on the ability of the patient to perform activities related to the topic of each section.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months after completion of treatmentPopulation: One patient experienced disease progression and was unable to continue to complete the required questionnaires. The second patient was removed from study due to non-compliance and did not complete the required questionnaires.
The Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS). The FACT-CNS consists of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Additional Concerns. Participants can choose 0 (Not At All) up to 4 (Very Much) for each question.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after end of treatmentPopulation: The first patient progressed while on treatment and the second patient was removed from study due to non-compliance.
Local control is lack of local failure. Local failure refers to the primary treated tumor after protocol therapy and corresponds to meeting both the following two criteria: 1) Increase in tumor dimension of 20% increase in the longest diameter of the target lesion tasking as reference the smallest longest diameter since the treatment started (referred to as local enlargement). 2) The measurable tumor with criteria meeting local enlargement should be avid on PET imaging (or bone scan) with uptake of a similar intensity as the pretreatment staging PET (or bone scan), or the measurable tumor should be biopsied confirming viable carcinoma.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Low Dose
Arm 2: High Dose
Serious adverse events
| Measure |
Arm 1: Low Dose
n=1 participants at risk
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
|
Arm 2: High Dose
n=1 participants at risk
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
100.0%
1/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
100.0%
1/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1
|
0.00%
0/1
|
Other adverse events
| Measure |
Arm 1: Low Dose
n=1 participants at risk
Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
|
Arm 2: High Dose
n=1 participants at risk
High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
|
|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/1
|
100.0%
1/1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1
|
100.0%
1/1
|
|
Investigations
Alkaline phosphatase
|
100.0%
1/1
|
100.0%
1/1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1
|
100.0%
1/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1
|
100.0%
1/1
|
Additional Information
Jeffrey Bradley, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place