Trial Outcomes & Findings for Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis (NCT NCT02699697)
NCT ID: NCT02699697
Last Updated: 2025-12-11
Results Overview
The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Up to 6 months post-treatment
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
Arm A (Control) 8 Gy x 1
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
32
|
27
|
Reasons for withdrawal
| Measure |
Arm A (Control) 8 Gy x 1
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Overall Study
Death
|
18
|
15
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Refused to follow up
|
1
|
1
|
|
Overall Study
Entered hospice care
|
5
|
2
|
|
Overall Study
Missing reason for discontinuation
|
6
|
5
|
Baseline Characteristics
Palliative Radiation Therapy in Reducing Pain in Patients With Bone Metastasis
Baseline characteristics by cohort
| Measure |
Arm A (Control) 8 Gy x 1
n=51 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=51 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 14.0 • n=237 Participants
|
64.8 years
STANDARD_DEVIATION 10.8 • n=243 Participants
|
63.35 years
STANDARD_DEVIATION 12.4 • n=480 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=237 Participants
|
21 Participants
n=243 Participants
|
43 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=237 Participants
|
30 Participants
n=243 Participants
|
59 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
50 Participants
n=237 Participants
|
50 Participants
n=243 Participants
|
100 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
40 Participants
n=237 Participants
|
42 Participants
n=243 Participants
|
82 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
9 Participants
n=237 Participants
|
6 Participants
n=243 Participants
|
15 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race · Asian Indian/Asian
|
1 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race · Unable to obtain
|
1 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
3 Participants
n=480 Participants
|
|
Currently using bisphosphonates/ Denosumab?
|
10 Participants
n=237 Participants
|
4 Participants
n=243 Participants
|
14 Participants
n=480 Participants
|
|
Any prior cancer therapy
|
32 Participants
n=237 Participants
|
24 Participants
n=243 Participants
|
56 Participants
n=480 Participants
|
|
History of weight loss?
|
18 Participants
n=237 Participants
|
16 Participants
n=243 Participants
|
34 Participants
n=480 Participants
|
|
Medical History
Myocardial infarction
|
3 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
|
Medical History
Congestive heart failure
|
2 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
|
Medical History
Peripheral vascular disease
|
2 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Medical History
Cerebrovascular disease
|
6 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
11 Participants
n=480 Participants
|
|
Medical History
Dementia
|
0 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Medical History
Chronic pulmonary disease
|
3 Participants
n=237 Participants
|
8 Participants
n=243 Participants
|
11 Participants
n=480 Participants
|
|
Medical History
Connective tissue disease
|
0 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Medical History
Peptic ulcer disease
|
2 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
|
Medical History
Liver disease
|
0 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Medical History
Diabetes
|
5 Participants
n=237 Participants
|
12 Participants
n=243 Participants
|
17 Participants
n=480 Participants
|
|
Medical History
Hemiplegia
|
1 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Medical History
Other cancer
|
14 Participants
n=237 Participants
|
15 Participants
n=243 Participants
|
29 Participants
n=480 Participants
|
|
Medical History
AIDS
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Medical History
Other sites of metastases
|
37 Participants
n=237 Participants
|
35 Participants
n=243 Participants
|
72 Participants
n=480 Participants
|
|
Medical History
Brain
|
9 Participants
n=237 Participants
|
8 Participants
n=243 Participants
|
17 Participants
n=480 Participants
|
|
Medical History
Liver
|
13 Participants
n=237 Participants
|
12 Participants
n=243 Participants
|
25 Participants
n=480 Participants
|
|
ECOG Performance Status
0-1
|
31 Participants
n=237 Participants
|
34 Participants
n=243 Participants
|
65 Participants
n=480 Participants
|
|
ECOG Performance Status
2-3
|
17 Participants
n=237 Participants
|
17 Participants
n=243 Participants
|
34 Participants
n=480 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months post-treatmentPopulation: Analysis was performed with death as a competing risk.
The primary analysis will use a one-sided Z-test for proportions to test the null hypothesis.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=45 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=46 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
Retreatment
|
3 Participants
|
3 Participants
|
|
Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2)
Death
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentMeasured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale
Continuous scale - 3 months
|
4.4 score on a scale
Standard Deviation 3.7
|
3.8 score on a scale
Standard Deviation 3.1
|
|
Change in Pain Intensity Assessed Using the Numerical Rating Pain Scale NRPS - Continuous Scale
Continuous scale - 6 months
|
4.2 score on a scale
Standard Deviation 3.6
|
4.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentMeasured on a continuous scale and will be compared between groups using 2-sample t-tests. Pain, on a 0-10 scale, and narcotic use, in daily oral morphine equivalents, by treatment arm assessed at 3 and 6 months post-treatment completion. The variable for pain response is categorical rather than continuous and will be compared between groups using a Fisher's exact test. The rating pain scale is from 0-10, with 0 being no pain, 8-10 worst possible pain.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use
Narcotic use in daily morphine equivalents - 6 months
|
5 MME per day
Standard Deviation 7.3
|
6 MME per day
Standard Deviation 5.0
|
|
Change in Narcotic Use Assessed Using the Numerical Rating Pain Scale NRPS - Narcotic Use
Narcotic use in daily morphine equivalents - 3 months
|
6 MME per day
Standard Deviation 18.2
|
9 MME per day
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentAnalyses will be performed that examine whether there are associations between quality of life and treatment outcome (re-treatment rates or amount of pain relief). Measured on a continuous scale and will be compared between groups using 2-sample t-tests. Either multiple logistic regression (for binary outcomes) models or analysis of covariance (ANCOVA) models for continuous outcomes will be used. The QLQ-C15-PAL has high sensitivity and specificity for identifying clinically important symptoms and functional health impairments. Scores range from 0 to 100 with higher values indicating a better quality of life in the Physical and Emotional Functioning and Quality of Life categories. Higher scores in Symptoms Scales categories indicates a worse quality of life. Most questions are rated on a 4-point Likert scale (1 = not at all to 4 = very much), but the global quality of life item uses a 7-point scale (1 = very poor to 7 = excellent)
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Emotional Functioning - 3 months
|
74.0 score on a scale
Standard Deviation 30.5
|
75.4 score on a scale
Standard Deviation 26.5
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Dyspnea
|
26.4 score on a scale
Standard Deviation 29.5
|
22.7 score on a scale
Standard Deviation 34.7
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Pain
|
52.7 score on a scale
Standard Deviation 30.3
|
52.2 score on a scale
Standard Deviation 31.5
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Appetite loss
|
37.5 score on a scale
Standard Deviation 37.2
|
25.8 score on a scale
Standard Deviation 25.1
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Constipation
|
29.3 score on a scale
Standard Deviation 30.9
|
31.9 score on a scale
Standard Deviation 38.2
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Quality of Life - 3 months
|
62.7 score on a scale
Standard Deviation 27.8
|
60.1 score on a scale
Standard Deviation 24.5
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Dyspnea
|
19.4 score on a scale
Standard Deviation 26.4
|
31.5 score on a scale
Standard Deviation 38.7
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Pain
|
37.5 score on a scale
Standard Deviation 28.5
|
55.6 score on a scale
Standard Deviation 37.0
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Appetite loss
|
25.0 score on a scale
Standard Deviation 35.2
|
27.8 score on a scale
Standard Deviation 38.3
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Physical Functioning - 6 months
|
87.0 score on a scale
Standard Deviation 14.9
|
64.2 score on a scale
Standard Deviation 31.3
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Physical Functioning - 3 months
|
65.7 score on a scale
Standard Deviation 28.5
|
72.2 score on a scale
Standard Deviation 24.9
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Emotional Functioning - 6 months
|
84.7 score on a scale
Standard Deviation 20.7
|
79.6 score on a scale
Standard Deviation 27.1
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Insomnia
|
33.3 score on a scale
Standard Deviation 31.1
|
27.3 score on a scale
Standard Deviation 28.4
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Fatigue
|
50.0 score on a scale
Standard Deviation 30.0
|
47.8 score on a scale
Standard Deviation 24.8
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (3 months) - Nausea/vomiting
|
22.2 score on a scale
Standard Deviation 23.4
|
16.7 score on a scale
Standard Deviation 19.9
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Insomnia
|
27.8 score on a scale
Standard Deviation 34.3
|
40.7 score on a scale
Standard Deviation 38.9
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Fatigue
|
31.9 score on a scale
Standard Deviation 26.1
|
48.1 score on a scale
Standard Deviation 31.3
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) Nausea/vomiting
|
22.2 score on a scale
Standard Deviation 21.7
|
33.3 score on a scale
Standard Deviation 34.3
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Symptom Scales (6 months) - Constipation
|
16.7 score on a scale
Standard Deviation 22.5
|
33.3 score on a scale
Standard Deviation 28.0
|
|
Change in Quality of Life Measured Using the Quality of Life Questionnaire (QLQ) Core(C)15-palliative (PAL)
Quality of Life - 6 months
|
79.2 score on a scale
Standard Deviation 12.6
|
63.9 score on a scale
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Up to 6 months post-treatmentWill be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Groups will be compared to determine whether there are any differences in the number or severity of toxicities. When comparing severity of toxicities between groups, chi-square tests will be examined. The Cochran-Armitage trend test can be used to determine if there is evidence a trend in severity of toxicities when comparing groups. Because of the patient population as well as the treatment, emphasis will be placed on gastrointestinal (GI disturbance, esophagitis, diarrhea, nausea, and vomiting), hematological (low blood counts or bleeding), spinal (bone fracture, compression fracture, insufficiency, or myelitis), and pulmonary toxicities (pneumonitis) and recorded by clinical research coordinators. Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to the event.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Incidence of Adverse Events - Grade 3 or Higher
Nausea - Grade 3
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Anemia - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Diarrhea - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Fatigue - Grade 3
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Fatigue - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Fatigue - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Pain - Grade 3
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Pain - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Pain - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Nausea - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Nausea - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Anemia - Grade 3
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dehydration - Grade 3
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dehydration - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dehydration - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dyspnea - Grade 3
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dyspnea - Grade 4
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Dyspnea - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Anemia - Grade 5
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Diarrhea - Grade 3
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events - Grade 3 or Higher
Diarrhea - Grade 4
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentAnalyses will be performed that examine whether there are associations between patient satisfaction and treatment outcome (re-treatment rates or amount of pain relief). Satisfaction will be measured by answering a series of questions with a scoring scale range of 1 (strongly agree) to 5 (strongly disagree). The scoring range for the Patient Satisfaction with Cancer Care (PSCC)-18 is 18 (best score) to 90 (worse score). A lower total score indicates higher satisfaction with cancer care.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)
6 months
|
25.4 score on a scale
Standard Deviation 10.0
|
26.0 score on a scale
Standard Deviation 10.1
|
|
Participants With Patient Satisfaction of Treatment Outcome - Patient Satisfaction With Cancer Care (PSCC-18)
3 months
|
25.8 score on a scale
Standard Deviation 8.9
|
26.3 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentThe Perceived Stress Scale (PSS) is a stress assessment instrumentto help understand how different situations affect feelings and perceived stress. Scoring scale is 1 (never) to 4 (very often) when monitoring stress, the higher the total score the more stress the participant has experienced. The Perceived Stress Scale (PSS-10) is scored by summing the responses to all 10 items, with a total score ranging from 0 to 40. To get the score, you first need to reverse the scoring for the positively worded items (items 4, 5, 7, and 8). A total score of 0-13 suggests low stress, 14-26 indicates moderate stress, and 27-40 represents high stress. Perceived helplessness (items 1, 2, 3, 6, 9, 10) - measuring an individual's feelings of a lack of control over their circumstances or their own emotions or reactions. Lack of self-efficacy (items 4, 5, 7, 8) - measuring an individual's perceived inability to handle problems.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Perceived self-efficacy total (6 months)
|
4.7 score on a scale
Standard Deviation 3.4
|
5.6 score on a scale
Standard Deviation 4.4
|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Total PSS-10 score (6 months)
|
10.6 score on a scale
Standard Deviation 7.2
|
14.5 score on a scale
Standard Deviation 10.7
|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Perceived self-efficacy total (3 months)
|
5.6 score on a scale
Standard Deviation 3.6
|
4.7 score on a scale
Standard Deviation 3.7
|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Total PSS-10 score (3 months)
|
14.2 score on a scale
Standard Deviation 8.1
|
13.0 score on a scale
Standard Deviation 8.6
|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Perceived helplessness total (6 months)
|
5.9 score on a scale
Standard Deviation 4.4
|
8.6 score on a scale
Standard Deviation 6.9
|
|
Participants With Perceived Stress of Treatment Outcome - Perceived Stress Scale (PSS-10)
Perceived helplessness total (3 months)
|
8.7 score on a scale
Standard Deviation 5.6
|
8.0 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: At 3 months and 6 months post-treatmentAssociation between social support and treatment outcomes will be assessed. Social support will be measured by answering a series of questions with a scoring scale range of 1 (definitely false for you) to 4 (definitely true for you). The total score is the sum of all items, ranging from 0 to 36. Sum the scores for the four items in each subscale (Appraisal, Belonging, and Tangible) to get a score ranging from 0 to 12 for each subscale. The higher the total score the more support the participants receive from their support network.
Outcome measures
| Measure |
Arm A (Control) 8 Gy x 1
n=19 Participants
Patients undergo 1 fraction of EBRT over 30 minutes.
|
Arm B (Treatment) 8 Gy x 2
n=24 Participants
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
|
|---|---|---|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Appraisal Support subscale total (3 months)
|
6.5 score on a scale
Standard Deviation 1.5
|
6.0 score on a scale
Standard Deviation 1.7
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Belonging Support subscale total (3 months)
|
5.8 score on a scale
Standard Deviation 1.4
|
6.0 score on a scale
Standard Deviation 1.9
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Tangible Support subscale total (3 months)
|
8.1 score on a scale
Standard Deviation 1.7
|
8.8 score on a scale
Standard Deviation 1.7
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Tangible Support subscale total (6 months)
|
8.5 score on a scale
Standard Deviation 1.4
|
8.7 score on a scale
Standard Deviation 1.0
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Total ISEL score (6 months)
|
20.9 score on a scale
Standard Deviation 2.2
|
21.4 score on a scale
Standard Deviation 1.4
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Total ISEL score (3 months)
|
20.2 score on a scale
Standard Deviation 3.3
|
20.8 score on a scale
Standard Deviation 4.3
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Appraisal Support subscale total (6 months)
|
6.3 score on a scale
Standard Deviation 1.3
|
6.1 score on a scale
Standard Deviation 0.8
|
|
Participants With Social Support Assessed Via Self-Reported Surveys
Belonging Support subscale total (6 months)
|
6.2 score on a scale
Standard Deviation 2.0
|
6.6 score on a scale
Standard Deviation 1.1
|
Adverse Events
ARM I (Palliative Radiation Therapy)
Serious events: 19 serious events
Other events: 32 other events
Deaths: 19 deaths
ARM II (Palliative Radiation Therapy)
Serious events: 37 serious events
Other events: 32 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
ARM I (Palliative Radiation Therapy)
n=51 participants at risk
Patients undergo 1 fraction of EBRT over 30 minutes.
External Beam Radiation Therapy: Undergo EBRT
Palliative Radiation Therapy: Undergo EBRT
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
ARM II (Palliative Radiation Therapy)
n=51 participants at risk
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
External Beam Radiation Therapy: Undergo EBRT
Palliative Radiation Therapy: Undergo EBRT
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Chills
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Death, NOS
|
37.3%
19/51 • Number of events 19 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
33.3%
17/51 • Number of events 17 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Fatigue
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Fever
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Gait disturbance
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Pain
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Lung infection
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedures complications, other
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Renal and urinary disorders
Acute kidney pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
Other adverse events
| Measure |
ARM I (Palliative Radiation Therapy)
n=51 participants at risk
Patients undergo 1 fraction of EBRT over 30 minutes.
External Beam Radiation Therapy: Undergo EBRT
Palliative Radiation Therapy: Undergo EBRT
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
ARM II (Palliative Radiation Therapy)
n=51 participants at risk
Patients undergo 2 fractions of EBRT over 30 minutes. The 2 fractions will be separated by 3-7 days.
External Beam Radiation Therapy: Undergo EBRT
Palliative Radiation Therapy: Undergo EBRT
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Ear and labyrinth disorders
Vestibular disorder
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Eye disorders
Blurred vision
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Eye disorders
Dry eye
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Eye disorders
Eye pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Constipation
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Diarrhea
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.0%
1/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Nausea
|
19.6%
10/51 • Number of events 10 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
13.7%
7/51 • Number of events 8 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Gastrointestinal disorders
Vomiting
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
11.8%
6/51 • Number of events 6 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Chills
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Edema, limbs
|
7.8%
4/51 • Number of events 4 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Fatigue
|
7.8%
4/51 • Number of events 4 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
19.6%
10/51 • Number of events 10 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Fever
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Non-cardiac chest pain
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
General disorders
Pain
|
13.7%
7/51 • Number of events 8 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
23.5%
12/51 • Number of events 12 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Infections and infestation
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Skin infection
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Fall
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Investigations
Lymphocyte count decreased
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Investigations
Platelet count decreased
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Investigations
Weight loss
|
7.8%
4/51 • Number of events 4 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Investigations
White blood cell decreased
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Anorexia
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
3/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
6/51 • Number of events 6 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
9.8%
5/51 • Number of events 5 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
13.7%
7/51 • Number of events 8 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Dysgeusia
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Seizure
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Spasticity
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Nervous system disorders
Tremor
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Psychiatric disorders
Anxiety
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Psychiatric disorders
Confusion
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Psychiatric disorders
Restlessness
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Reproductive system and breast disorders
Genital edema
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.8%
4/51 • Number of events 4 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
17.6%
9/51 • Number of events 9 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 3 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
3.9%
2/51 • Number of events 2 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/51 • Number of events 1 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
0.00%
0/51 • Up to 6 months post-treatment, 6 months in Arm I (8 Gy x 1 fraction) and 6 months and 1 week for Arm II (8 Gy x 2 fractions)
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 3367135440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place