Trial Outcomes & Findings for One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors (NCT NCT06236516)
NCT ID: NCT06236516
Last Updated: 2026-05-01
Results Overview
Feasibility is defined as the successful completion of the ONE STOP workflow through treatment delivery in at least 70% of patients. Successful completion of the workflow is defined as ONE STOP plan creation and delivery of the fraction using the study workflow in one on-table attempt. Unsuccessful completion of the workflow is defined as multiple attempts of the ONE STOP workflow for one patient without treatment delivery such that the study workflow is abandoned and a traditional one-, three-, or five-fraction plan is delivered.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Day 1
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
One Fraction SBRT
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
One Fraction SBRT
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors
Baseline characteristics by cohort
| Measure |
One Fraction SBRT
n=10 Participants
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
Age, Continuous
|
68.50 years
n=14 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Day 1Feasibility is defined as the successful completion of the ONE STOP workflow through treatment delivery in at least 70% of patients. Successful completion of the workflow is defined as ONE STOP plan creation and delivery of the fraction using the study workflow in one on-table attempt. Unsuccessful completion of the workflow is defined as multiple attempts of the ONE STOP workflow for one patient without treatment delivery such that the study workflow is abandoned and a traditional one-, three-, or five-fraction plan is delivered.
Outcome measures
| Measure |
One Fraction SBRT
n=10 Participants
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
Feasibility of the ONE STOP Workflow as Measured by the Number of Participants With Successful Completion of the ONE STOP Workflow Through Treatment Delivery
|
8 Participants
|
Adverse Events
One Fraction SBRT
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
One Fraction SBRT
n=10 participants at risk
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
Other adverse events
| Measure |
One Fraction SBRT
n=10 participants at risk
Consenting and eligible patients will receive a prescription dose of 25-34 Gy in one fraction with adaptation based on daily anatomic changes as per clinical standard of care.
|
|---|---|
|
General disorders
Non-Cardiac Chest Pain
|
20.0%
2/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Pain
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Fascia Strain
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
20.0%
2/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Skin and subcutaneous tissue disorders
Feet Discoloration
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Fever
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Flu-Like Symptoms
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Gait Disturbance
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Edema Limbs
|
10.0%
1/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Adverse events and all-cause mortality were tracked from start of treatment (Day 1) through 3 months after completion of SBRT, on average 3 months.
|
Additional Information
Pamela Samson, M.D., MPHS
Washington University School of Medicine
Phone: 314-801-3806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place