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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

At 6 months

Results posted on

2024-08-29

Participant Flow

Participant milestones

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

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

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 months

Population: Participants must have received treatment and had a 6 month disease assessment to be evaluable for this outcome measure.

Outcome measures

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 events: 42 serious events
Other events: 31 other events
Deaths: 33 deaths

Serious adverse events

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

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

Phone: 314-747-1786

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place