Trial Outcomes & Findings for Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine (NCT NCT03878485)
NCT ID: NCT03878485
Last Updated: 2024-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
First on-table attempt of first fraction of radiation (an average of 1 day)
Results posted on
2024-07-25
Participant Flow
Participant milestones
| Measure |
Stereotactic MRI-guided Adaptive Radiotherapy
-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).
|
|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
|
10
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Same-session MR-only Simulation and Treatment With Stereotactic MRI-guided Adaptive Radiotherapy (SMART) for Oligometastases of the Spine
Baseline characteristics by cohort
| Measure |
Stereotactic MRI-guided Adaptive Radiotherapy
n=10 Participants
-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).
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|---|---|
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Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
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2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: First on-table attempt of first fraction of radiation (an average of 1 day)Outcome measures
| Measure |
Stereotactic MRI-guided Adaptive Radiotherapy
n=10 Participants
-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).
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|---|---|
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Number of Participants to Receive Delivery of the First Fraction of Same-session MRI-only Simulation and Treatment With SMART on the First On-table Attempt
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8 Participants
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Adverse Events
Stereotactic MRI-guided Adaptive Radiotherapy
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Stereotactic MRI-guided Adaptive Radiotherapy
n=10 participants at risk
-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).
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|---|---|
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Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
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|
Gastrointestinal disorders
Abdominal pain
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10.0%
1/10 • Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
|
|
General disorders
Disease progression
|
10.0%
1/10 • Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
|
Other adverse events
| Measure |
Stereotactic MRI-guided Adaptive Radiotherapy
n=10 participants at risk
-Radiotherapy will consist of stereotactic body therapy to the spine, to be given over either a two or five fraction course, delivered once daily or once every other day for a period of one to two weeks, for a total of two or five treatments (depending on whether a 2 or 5 fraction course is selected).
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|---|---|
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Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
|
|
Gastrointestinal disorders
Vomiting
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10.0%
1/10 • Adverse events and all-cause mortality were collected from start of treatment through 3-month post-treatment follow-up visit.
The following adverse events were not collected: grade 1-2 events regardless of relatedness, grade 3-4 events that predate SBRT, and grade 3-4 events that are not at least probably attributable to treatment.
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Additional Information
Dr. Clifford Robinson
Washington University School of Medicine
Phone: 314-362-8567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place