Trial Outcomes & Findings for Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers (NCT NCT04553471)
NCT ID: NCT04553471
Last Updated: 2024-08-29
Results Overview
COMPLETED
NA
70 participants
At 6 months
2024-08-29
Participant Flow
Participant milestones
| Measure |
SBRT
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
SBRT
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|
|
Overall Study
Did not start treatment on protocol
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
Baseline characteristics by cohort
| Measure |
SBRT
n=70 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Participants must have received treatment and had a 6 month disease assessment to be evaluable for this outcome measure.
Outcome measures
| Measure |
SBRT
n=32 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Rate of Local Control
|
29 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 6 months-Graded using CTCAE v5.0
Outcome measures
| Measure |
SBRT
n=66 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score. * PROMIS Physical Function is a 10-item questionnaire assessing current self-reported physical function with answers ranging from 1 = cannot do to 5 = not at all/without any difficulty. * A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation. * A high T-Score for PROMIS Physical Function Assessment correlates to a higher physical function, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better functioning, than the reference population mean.
Outcome measures
| Measure |
SBRT
n=38 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=39 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=31 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=21 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=15 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline - PROMIS Physical Function Assessment
|
2.22 T-Score
Standard Deviation 5.976098077
|
-0.27 T-Score
Standard Deviation 6.464353622
|
2.01 T-Score
Standard Deviation 8.493109161
|
2.76 T-Score
Standard Deviation 8.144051291
|
-0.72 T-Score
Standard Deviation 6.097212478
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score. * PROMIS Global Health is a 2-item questionnaire assessing current self-reported physical function with answers ranging from 1=poor/not all all to 5=excellent/completely * A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation. * A high T-Score for PROMIS Global Health Physical Assessment correlates to a higher global health physical assessment, or positive outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or better physical assessment, than the reference population mean
Outcome measures
| Measure |
SBRT
n=41 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=39 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=31 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=20 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=16 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline-PROMIS Global Health Physical Assessment
|
1.36 T-Score
Standard Deviation 4.885644726
|
0.40 T-Score
Standard Deviation 5.629643682
|
0.95 T-Score
Standard Deviation 6.704716684
|
2.63 T-Score
Standard Deviation 7.152040563
|
1.06 T-Score
Standard Deviation 5.996095952
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score. * PROMIS Depression is a 4-item questionnaire assessing current self-reported depression with answers ranging from 1=never to 5=always * A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation. * A high T-Score for PROMIS Depression Assessment correlates to more depression, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse depression, than the reference population mean
Outcome measures
| Measure |
SBRT
n=40 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=39 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=32 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=20 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=16 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline-PROMIS Depression Assessment
|
1.01 T-Score
Standard Deviation 6.575515969
|
0.72 T-Score
Standard Deviation 7.013388007
|
-0.15 T-Score
Standard Deviation 7.290691563
|
1.01 T-Score
Standard Deviation 9.929482946
|
-2.43 T-Score
Standard Deviation 8.78069853
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* Each value is the mean of the changes from baseline PROMIS T-Score to timepoint PROMIS T-score. * PROMIS Anxiety is a 29-item questionnaire assessing current self-reported anxiety with answers ranging from 1=never to 5=always * A PROMIS T-Score of 50 corresponds to the mean of the general population. A magnitude of 10 on the PROMIS scale corresponds to a standard deviation. * A high T-Score for PROMIS Anxiety Assessment correlates to more anxiety, or negative outcome. Since the scale is standardized a score of 60 is one standard deviation higher, or worse anxiety, than the reference population mean.
Outcome measures
| Measure |
SBRT
n=42 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=40 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=32 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=20 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=16 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline-PROMIS Anxiety Assessment
|
1.16 T-Score
Standard Deviation 7.520188855
|
0.12 T-Score
Standard Deviation 6.799064792
|
-1.66 T-Score
Standard Deviation 8.797717813
|
-0.15 T-Score
Standard Deviation 8.436791296
|
-4.34 T-Score
Standard Deviation 9.955565864
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* Each value is the mean of the changes from baseline Numeric Pain Scale score to timepoint Numeric Pain Scale score. * The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain * The Numeric Pain Rating Scale (NPRS) measures pain intensity in adults using a scale from 0 or "no pain" to 10 or "worst possible pain." This measure is unidimensional and evaluated on the 0-10 scale. A higher value on the scale correlates with a worse pain and a worse outcome.
Outcome measures
| Measure |
SBRT
n=23 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=24 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=18 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=14 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=13 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline-Numeric Pain Scale
|
0.87 score on a scale
Standard Deviation 3.911571967
|
-0.38 score on a scale
Standard Deviation 4.209848701
|
-0.83 score on a scale
Standard Deviation 2.357715744
|
-0.29 score on a scale
Standard Deviation 3.709210396
|
-0.77 score on a scale
Standard Deviation 2.832956234
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question.
* The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms. * Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5. * Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5 * Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Outcome measures
| Measure |
SBRT
n=20 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=15 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=15 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=12 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=9 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
n=5 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of decreased appetite
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of vomiting
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of heartburn
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of heartburn
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of bloating
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of bloating
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of hiccups
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of hiccups
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of diarrhea
|
1 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of abdominal pain
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Abdominal pain interference
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Bowel movement control loss interference
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of numbness/tingling in hands or feet
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of dizziness
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Dizziness interference
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of concentration problems
|
1 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Concentration problems interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of pain
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Pain interference
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of insomnia
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Insomnia interference
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of fatigue
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 2.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Fatigue interference
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Anxiety interference
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of depression
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of depression
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Depression interference
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Sadness or happiness interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Decreased appetite interference
|
1 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of nausea
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of nausea
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Numbness or tingling in hands or feet interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of vomiting
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of constipation
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of abdominal pain
|
2 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of bowel movement control loss
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Severity of memory problems
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Memory problem interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
Frequency of pain
|
3 score on a scale
Interval 1.0 to 5.0
|
4 score on a scale
Interval 1.0 to 5.0
|
4 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question.
* The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms. * Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5. * Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5 * How often options include 1=never, 2=rarely, 3=occasionally, 4=frequently, 5=almost constantly * Severity of difficulty getting/keeping erection, ejaculation problems, decreased sexual interest, vaginal pain 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe * Experienced unusual vaginal discharge options include 1=not at all, 2=a little bit, 3 = somewhat, 4=quite a bit, 5=very much
Outcome measures
| Measure |
SBRT
n=21 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=14 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=13 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=10 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=7 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
n=6 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of numbness/tingling in hands or feet
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Numbness or tingling in hands or feet interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of dizziness
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
2.5 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Dizziness interference
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of memory problems
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of pain
|
4 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of insomnia
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Insomnia interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Depression interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of pain during vaginal sex
|
1 score on a scale
Interval 1.0 to 1.0
|
—
|
1 score on a scale
Only 1 participant was evaluable.
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of urination frequency
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2.5 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequent urination interfering
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of urine leakage
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Urine leakage frequency
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of concentration problems
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Concentration problems interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Memory problem interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of pain
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Pain interference
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 2.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of difficulty getting/keeping an erection
|
1 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of fatigue
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Fatigue interference
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2.5 score on a scale
Interval 2.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 2.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Anxiety interference
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of depression
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of depression
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Sadness or happiness interference
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Experienced unusual vaginal discharge
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of vaginal dryness
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of pain/burning with urination
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of urge to urinate
|
1.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Urge to urinate interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Frequency of ejaculation problems
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
Severity of decreased sexual interest
|
1.5 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included. If the participant did not answer a question on the questionnaire then they are not included for that question.
* The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms. * Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5. * Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5 * Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Outcome measures
| Measure |
SBRT
n=2 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=3 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=2 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=2 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=1 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Fatigue interference
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3.5 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 2.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Dizziness interference
|
2.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 2.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Memory problem interference
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Frequency of pain
|
3 score on a scale
Interval 2.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
4.5 score on a scale
Interval 4.0 to 5.0
|
4.5 score on a scale
Interval 4.0 to 5.0
|
2 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of pain
|
2.5 score on a scale
Interval 2.0 to 3.0
|
4 score on a scale
Interval 4.0 to 5.0
|
4.5 score on a scale
Interval 4.0 to 5.0
|
4 score on a scale
Interval 4.0 to 4.0
|
2 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Pain interference
|
2.5 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 3.0 to 3.0
|
4 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 3.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of insomnia
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 3.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Insomnia interference
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of fatigue
|
3.5 score on a scale
Interval 2.0 to 5.0
|
3.5 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Frequency of depression
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of dry mouth
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of difficulty swallowing
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of mouth or throat sores
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Mouth or throat sores interference
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of skin cracking at corners of mouth
|
1 score on a scale
Interval 1.0 to 1.0
|
3 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of hoarse voice
|
1.5 score on a scale
Interval 1.0 to 2.0
|
3 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of numbness/tingling in hands or feet
|
3 score on a scale
Interval 2.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
3.5 score on a scale
Interval 3.0 to 4.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Numbness or tingling in hands or feet interference
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of dizziness
|
3 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 2.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of concentration problems
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Concentration problems interference
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of memory problems
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Frequency of anxiety
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of anxiety
|
2 score on a scale
Interval 1.0 to 3.0
|
2.5 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Anxiety interference
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of depression
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Depression interference
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Frequency of sadness or unhappiness
|
3 score on a scale
Interval 3.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 2.0 to 2.0
|
2.5 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Severity of sadness or unhappiness
|
3.5 score on a scale
Interval 3.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2.5 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Only 1 participant was evaluable.
|
—
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
Sadness or happiness interference
|
2.5 score on a scale
Interval 2.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 1.0
|
2 score on a scale
Interval 2.0 to 2.0
|
1 score on a scale
Only 1 participant was evaluable.
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 monthsPopulation: If a participant did not complete the questionnaire at the timepoint then they are not included.
* The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities. The higher the score the worst the symptoms. * Severity options include none=1, mild=2, moderate=3, severe = 4, very severe=5. * Interference options include not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5 * Frequency options include never=1, rarely=2, occasionally=3, frequently=4, almost constantly=5
Outcome measures
| Measure |
SBRT
n=18 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-30 Days
n=11 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-3 Months
n=11 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-6 Months
n=10 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT-12 Months
n=7 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
SBRT - 12 Months
n=5 Participants
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|---|---|---|---|---|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of hoarse voice
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of shortness of breath
|
3 score on a scale
Interval 2.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Shortness of breath interference
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of wheezing
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Dizziness interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 1.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Concentration problems interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of memory problems
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Memory problem interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of pain
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of insomnia
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
3 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of fatigue
|
3 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
2.5 score on a scale
Interval 2.0 to 4.0
|
3 score on a scale
Interval 2.0 to 3.0
|
3 score on a scale
Interval 2.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Fatigue interference
|
2.5 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 2.0 to 5.0
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of anxiety
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of depression
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of depression
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Depression interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Sadness or happiness interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of numbness/tingling in hands or feet
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Numbness or tingling in hands or feet interference
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of heartburn
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of decreased appetite
|
2 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Decreased appetite interference
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of nausea
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of dizziness
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of nausea
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of vomiting
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of vomiting
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of heartburn
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of bloating
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of bloating
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of hiccups
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of hiccups
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of concentration problems
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of pain
|
2 score on a scale
Interval 1.0 to 5.0
|
3 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 2.0 to 5.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Pain interference
|
1 score on a scale
Interval 1.0 to 5.0
|
3.5 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 5.0
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Insomnia interference
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 5.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Anxiety interference
|
1 score on a scale
Interval 1.0 to 4.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Frequency of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
Severity of sadness or unhappiness
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 4.0
|
1.5 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
Adverse Events
SBRT
Serious adverse events
| Measure |
SBRT
n=66 participants at risk
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
Accidental morphine overdose
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Infections and infestations
Adenovirus upper respiratory infection
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Anal pain
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Blood and lymphatic system disorders
Anemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Infections and infestations
COVID19
|
4.5%
3/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
Disease progression
|
42.4%
28/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Diverticulitis
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
4/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
Fever
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Cardiac disorders
Heart failure
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Infections and infestations
Infection attributed to port
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Infections and infestations
Lung infection
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Cardiac disorders
Mass on right ventricle
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Investigations
Neutrophil count decreased
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Reproductive system and breast disorders
Post-menopause bleeding
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Infections and infestations
Sepsis
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Stroke
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
THA failure with pseudotumor formation
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Vascular disorders
Thromboembolic event
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
Other adverse events
| Measure |
SBRT
n=66 participants at risk
5-fraction Lattice SBRT delivered to 20 Gy with a simultaneous integrated boost (SIB) to 66.7 Gy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
8/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary embolism
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
Fatigue
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Gastritis (epigastric pain)
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Investigations
Hyponatremia
|
3.0%
2/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Investigations
Lymphocyte count decreased
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
General disorders
Pain (pelvis/hip)
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Seizure
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Vascular disorders
Thromboembolic event
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Adverse events and all-cause mortality were collected from start of treatment through 360 days following completion of radiotherapy.
|
Additional Information
Pamela Samson, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place