This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors (≥ 4.5 cm) planning to undergo palliative radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Treatment will take approximately 2 weeks.
-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up
Washington University School of Medicine
St Louis, Missouri, United States
Rate of Local Control
Time frame: At 6 months
Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
-Graded using CTCAE v5.0
Time frame: Through 6 months
Mean Change From Baseline - PROMIS Physical Function Assessment
* 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.
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Global Health Physical Assessment
* 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
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
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Mean Change From Baseline-PROMIS Depression Assessment
* 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
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-PROMIS Anxiety Assessment
* 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.
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Mean Change From Baseline-Numeric Pain Scale
* 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.
Time frame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
* 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
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
* 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
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
* 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
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
* 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
Time frame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months