Trial Outcomes & Findings for Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction (NCT NCT04939246)
NCT ID: NCT04939246
Last Updated: 2025-07-17
Results Overview
To be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
Single-fraction SABR
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Screening
STARTED
|
30
|
|
Screening
COMPLETED
|
30
|
|
Screening
NOT COMPLETED
|
0
|
|
During Treatment
STARTED
|
30
|
|
During Treatment
COMPLETED
|
30
|
|
During Treatment
NOT COMPLETED
|
0
|
|
After Treatment
STARTED
|
30
|
|
After Treatment
COMPLETED
|
23
|
|
After Treatment
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Single-fraction SABR
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
After Treatment
Death
|
4
|
|
After Treatment
Lost to Follow-up
|
1
|
|
After Treatment
Discharged to hospice
|
2
|
Baseline Characteristics
Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
Baseline characteristics by cohort
| Measure |
Single-fraction SABR
n=32 lesions
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active, able to carry on all pre-disease performance without restriction)
|
12 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Ambulatory, able to carry out work of a light or sedentary nature)
|
18 participants
n=5 Participants
|
|
Previous Systemic Therapy for Metastatic Disease
Chemotherapy Only
|
10 participants
n=5 Participants
|
|
Previous Systemic Therapy for Metastatic Disease
Immunotherapy Only
|
2 participants
n=5 Participants
|
|
Previous Systemic Therapy for Metastatic Disease
Chemotherapy and Immunotherapy
|
2 participants
n=5 Participants
|
|
Previous Systemic Therapy for Metastatic Disease
None
|
16 participants
n=5 Participants
|
|
Total Number of Treated Lesions
|
32 lesions
n=5 Participants
|
|
Maximum Size of Treated Lesions
|
1.7 cm
n=20 lesions
|
|
Primary or Metastatic Lesions
Primary
|
2 lesions
n=20 lesions
|
|
Primary or Metastatic Lesions
Metastatic
|
30 lesions
n=20 lesions
|
|
Anatomic Location
Lung
|
11 lesions
n=20 lesions
|
|
Anatomic Location
Adrenal gland
|
9 lesions
n=20 lesions
|
|
Anatomic Location
Abdominal/pelvic lymph node
|
6 lesions
n=20 lesions
|
|
Anatomic Location
Liver
|
5 lesions
n=20 lesions
|
|
Anatomic Location
Pancreas
|
1 lesions
n=20 lesions
|
|
Primary Tumor Location
Colon/rectum
|
16 lesions
n=20 lesions
|
|
Primary Tumor Location
Lung
|
10 lesions
n=20 lesions
|
|
Primary Tumor Location
Kidney
|
2 lesions
n=20 lesions
|
|
Primary Tumor Location
Esophagus
|
1 lesions
n=20 lesions
|
|
Primary Tumor Location
Pancreas
|
1 lesions
n=20 lesions
|
|
Primary Tumor Location
Anal canal
|
1 lesions
n=20 lesions
|
|
Primary Tumor Location
Tonsil
|
1 lesions
n=20 lesions
|
|
Primary Tumor Definitively Managed
Yes
|
27 Participants
n=5 Participants
|
|
Primary Tumor Definitively Managed
No
|
1 Participants
n=5 Participants
|
|
Primary Tumor Definitively Managed
Not Applicable
|
2 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
17 Participants
n=5 Participants
|
|
Histology
Non-small cell lung carcinoma
|
7 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
3 Participants
n=5 Participants
|
|
Histology
Renal cell carcinoma
|
2 Participants
n=5 Participants
|
|
Histology
Small cell lung carcinoma
|
1 Participants
n=5 Participants
|
|
Interval from Initial Diagnosis to Enrolment
|
20.1 months
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearTo be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Number of Participants With SABR Successfully Delivered in One Fraction
|
30 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearNumber of patients that meet the following criteria: 1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Number of Patients Demonstrating Tolerability
Did not meet toxicity criteria
|
28 Participants
|
|
Number of Patients Demonstrating Tolerability
Grade 3 or higher acute toxicity attributable to SABR (excludes Grade 5 toxicities in next category)
|
2 Participants
|
|
Number of Patients Demonstrating Tolerability
Grade 5 toxicity attributed to SABR
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAssessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated with Kaplan-Meier and corresponding 95% confidence interval from the time of study treatment. Target lesion: * Complete response (CR): Disappearance of all target lesions * Partial response (PR): \>30% decrease in the sum of the diameters of target lesions * Stable disease (SD): Target lesion has neither sufficient decrease to qualify as a PR or sufficient increase to qualify as progressive disease (PD) * PD: At least a 20% increase in the sum of the diameters of target lesions an absolute increase of at least 5 mm Non-target lesion: * CR: Disappearance of all non-target lesions * SD: Persistence of ≥1 non-target lesions * PD: Appearance of ≥1 new lesions or unequivocal progression of existing non-target lesions Overall: * CR: Target CR+non-target CR * PR: Target CR/PR+non-target non-PD * SD: Target SD+non-target non-PD * PD: Anything else Local control=CR+PR+SD using overall response.
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
One-year Local Control
|
96.2 percentage of participants
Interval 88.8 to 100.0
|
SECONDARY outcome
Timeframe: 12 monthsPercent of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Percent of Participants With One-year Overall Survival
|
86.3 percentage of participants
Interval 73.8 to 98.8
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants with acute and late toxicities defined as grade 3 or higher toxicity attributable to SABR will be determined. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR.
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Number of Participants With Acute and Late Toxicity Results
Acute
|
2 participants
|
|
Number of Participants With Acute and Late Toxicity Results
Late
|
0 participants
|
SECONDARY outcome
Timeframe: baseline, 3, 6, 9, and 12 months after treatmentPatient-reported quality of life will be determined using the Functional Assessment of Cancer Therapy - General (FACT-G) survey instrument. FACT-G is a 27-item questionnaire that covers four sub-domains: physical (7 items), social (7 items), emotional, (6 items), and functional (7 items) well-being. Each question is scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reversed. After reversal of specified items, the sub-domain scores are totaled, then multiplied by the number of items in the sub-domain, and then divided by the number of items the participant answered. The scores for each sub-domain are 0 (worst well-being) to 24 (best emotional well-being) or 28 (best physical, social, or functional well-being). The total scores can range from 0 (worst overall well-being) to 108 (best overall well-being).
Outcome measures
| Measure |
Single-fraction SABR
n=30 Participants
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Change in Participant Reported Quality of Life Questionnaire
Baseline
|
84 score on a scale (FACT-G)
Interval 29.2 to 112.0
|
|
Change in Participant Reported Quality of Life Questionnaire
3 Months
|
85 score on a scale (FACT-G)
Interval 56.0 to 104.0
|
|
Change in Participant Reported Quality of Life Questionnaire
6 Months
|
69 score on a scale (FACT-G)
Interval 0.0 to 104.0
|
|
Change in Participant Reported Quality of Life Questionnaire
9 Months
|
91 score on a scale (FACT-G)
Interval 0.0 to 108.0
|
|
Change in Participant Reported Quality of Life Questionnaire
12 Months
|
93 score on a scale (FACT-G)
Interval 65.2 to 108.0
|
Adverse Events
Single-fraction SABR
Serious events: 3 serious events
Other events: 28 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Single-fraction SABR
n=30 participants at risk
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
Cardiac disorders
Pericardial Effusion
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Single-fraction SABR
n=30 participants at risk
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
|
|---|---|
|
General disorders
Fatigue
|
40.0%
12/30 • Number of events 13 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
30.0%
9/30 • Number of events 9 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Number of events 7 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
4/30 • Number of events 5 • 1 year
|
|
Vascular disorders
Hypertension
|
13.3%
4/30 • Number of events 4 • 1 year
|
|
Investigations
Creatinine Increased
|
13.3%
4/30 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Infections and infestations
Urinary Tract infection
|
6.7%
2/30 • Number of events 3 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Investigations
Investigations, Other - Platelet count increased
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.7%
2/30 • Number of events 2 • 1 year
|
Additional Information
Director, Concept Development & Data Management
Miami Cancer Institute at Baptist Health, Inc.
Phone: (786) 527-9546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place