Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord (NCT NCT00631670)
NCT ID: NCT00631670
Last Updated: 2012-02-03
Results Overview
Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.
COMPLETED
NA
21 participants
2 yrs
2012-02-03
Participant Flow
Participant milestones
| Measure |
Single Treatment Group
15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
0
|
|
Overall Study
COMPLETED
|
21
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord
Baseline characteristics by cohort
| Measure |
Single Treatment Group
n=21 Participants
15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=39 Participants
|
—
|
0 participants
n=35 Participants
|
|
Age Categorical
Between 18 and 65 years
|
13 participants
n=39 Participants
|
—
|
13 participants
n=35 Participants
|
|
Age Categorical
>=65 years
|
8 participants
n=39 Participants
|
—
|
8 participants
n=35 Participants
|
|
Age Continuous
|
58.5 years
STANDARD_DEVIATION 15.9 • n=39 Participants
|
—
|
58.5 years
STANDARD_DEVIATION 15.9 • n=35 Participants
|
|
Gender
Female
|
9 participants
n=39 Participants
|
—
|
9 participants
n=35 Participants
|
|
Gender
Male
|
12 participants
n=39 Participants
|
—
|
12 participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
—
|
21 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 yrsToxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.
Outcome measures
| Measure |
Single Treatment Group
n=21 Participants
15 Gy dose in one radiation treatment
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
|
|---|---|---|
|
Toxicity
mild acute toxicity
|
14 participants
|
—
|
|
Toxicity
moderate acute toxicity
|
0 participants
|
—
|
|
Toxicity
severe acute toxicity
|
0 participants
|
—
|
|
Toxicity
Late toxicity
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearNumber of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Outcome measures
| Measure |
Single Treatment Group
n=25 tumors
15 Gy dose in one radiation treatment
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
|
|---|---|---|
|
Local Control
|
24 tumors
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 6 patients presented with tumor-related deficits before treatment.
Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.
Outcome measures
| Measure |
Single Treatment Group
n=6 Participants
15 Gy dose in one radiation treatment
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
|
|---|---|---|
|
Neurologic Function
improved neurologic function
|
0 participants
|
—
|
|
Neurologic Function
unchanged neurologic function
|
6 participants
|
—
|
|
Neurologic Function
worse neurologic function
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients who reported pain at baseline
Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.
Outcome measures
| Measure |
Single Treatment Group
n=14 Participants
15 Gy dose in one radiation treatment
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
|
|---|---|---|
|
Pain Relief
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: One yearNumber of patients alive at one year after treatment
Outcome measures
| Measure |
Single Treatment Group
n=21 Participants
15 Gy dose in one radiation treatment
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
|
|---|---|---|
|
Overall One Year Survival
|
5 participants
|
—
|
Adverse Events
Single Treatment Group
25 Treatments Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Treatment Group
n=21 participants at risk
15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
|
25 Treatments Group
25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
|
|---|---|---|
|
Gastrointestinal disorders
Grade 1 Nausea
|
42.9%
9/21 • Number of events 9 • 2 years
|
—
0/0 • 2 years
|
|
Gastrointestinal disorders
Grade 2 Pharyngitis
|
23.8%
5/21 • Number of events 5 • 2 years
|
—
0/0 • 2 years
|
Additional Information
Bridget Fitzgerald, Clinical trials coordinator
University of Florida, Dept. of Radiation Oncology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place