Trial Outcomes & Findings for Online Proton Adaptive Radiotherapy (NCT NCT06310655)
NCT ID: NCT06310655
Last Updated: 2026-06-08
Results Overview
Feasibility will be defined as successful completion of the online adaptive proton radiotherapy workflow in at least 70% of planned adaptive fractions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Through end of treatment (up to 2 weeks)
Results posted on
2026-06-08
Participant Flow
Participant milestones
| Measure |
Proton Stereotactic Body Radiotherapy (SBRT)
All patients will receive standard of care proton SBRT either daily or every other day for a total of 5 fractions. At the time of each treatment, the initial pre-plan will be generated on the patient and assessed for coverage and safety. An adaptive plan based on the patient's anatomy that day will also be generated and then compared to the initial pre-plan. The optimal treatment plan will be chosen and administered to the patient on that day. This process will be repeated for each fraction for every patient.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Online Proton Adaptive Radiotherapy
Baseline characteristics by cohort
| Measure |
Proton Stereotactic Body Radiotherapy (SBRT)
n=10 Participants
All patients will receive standard of care proton SBRT either daily or every other day for a total of 5 fractions. At the time of each treatment, the initial pre-plan will be generated on the patient and assessed for coverage and safety. An adaptive plan based on the patient's anatomy that day will also be generated and then compared to the initial pre-plan. The optimal treatment plan will be chosen and administered to the patient on that day. This process will be repeated for each fraction for every patient.
|
|---|---|
|
Age, Continuous
|
61.1 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Through end of treatment (up to 2 weeks)Feasibility will be defined as successful completion of the online adaptive proton radiotherapy workflow in at least 70% of planned adaptive fractions.
Outcome measures
| Measure |
Proton Stereotactic Body Radiotherapy (SBRT)
n=10 Participants
All patients will receive standard of care proton SBRT either daily or every other day for a total of 5 fractions. At the time of each treatment, the initial pre-plan will be generated on the patient and assessed for coverage and safety. An adaptive plan based on the patient's anatomy that day will also be generated and then compared to the initial pre-plan. The optimal treatment plan will be chosen and administered to the patient on that day. This process will be repeated for each fraction for every patient.
|
|---|---|
|
Feasibility of Online Proton Adaptive Radiotherapy
|
10 Participants
|
SECONDARY outcome
Timeframe: From start of treatment through 3 monthsAdverse events (AEs) are graded per CTCAE v5.0.
Outcome measures
| Measure |
Proton Stereotactic Body Radiotherapy (SBRT)
n=10 Participants
All patients will receive standard of care proton SBRT either daily or every other day for a total of 5 fractions. At the time of each treatment, the initial pre-plan will be generated on the patient and assessed for coverage and safety. An adaptive plan based on the patient's anatomy that day will also be generated and then compared to the initial pre-plan. The optimal treatment plan will be chosen and administered to the patient on that day. This process will be repeated for each fraction for every patient.
|
|---|---|
|
Safety of Online Proton Adaptive Radiotherapy as Measured by the Number of Grade 2 and Higher Radiation-related Toxicities
|
1 number of grade 2+ RT related AEs
|
Adverse Events
Proton Stereotactic Body Radiotherapy (SBRT)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Proton Stereotactic Body Radiotherapy (SBRT)
n=10 participants at risk
All patients will receive standard of care proton SBRT either daily or every other day for a total of 5 fractions. At the time of each treatment, the initial pre-plan will be generated on the patient and assessed for coverage and safety. An adaptive plan based on the patient's anatomy that day will also be generated and then compared to the initial pre-plan. The optimal treatment plan will be chosen and administered to the patient on that day. This process will be repeated for each fraction for every patient.
|
|---|---|
|
Gastrointestinal disorders
Bowel obstruction
|
10.0%
1/10 • - Adverse events for patients were collected from start of treatment through 3 months post-end of SBRT. - All cause mortality was collected from the start of treatment through completion of follow-up 3 months post end of SBRT
All adverse events were collected with the exception of grade 1 AEs regardless of relatedness to treatment, and grade 2-4 AEs that are unlikely related or definitely not related to treatment. If the adverse event met the definition of a serious adverse event, it was collected regardless of attribution.
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • - Adverse events for patients were collected from start of treatment through 3 months post-end of SBRT. - All cause mortality was collected from the start of treatment through completion of follow-up 3 months post end of SBRT
All adverse events were collected with the exception of grade 1 AEs regardless of relatedness to treatment, and grade 2-4 AEs that are unlikely related or definitely not related to treatment. If the adverse event met the definition of a serious adverse event, it was collected regardless of attribution.
|
|
General disorders
Disease Progression
|
10.0%
1/10 • - Adverse events for patients were collected from start of treatment through 3 months post-end of SBRT. - All cause mortality was collected from the start of treatment through completion of follow-up 3 months post end of SBRT
All adverse events were collected with the exception of grade 1 AEs regardless of relatedness to treatment, and grade 2-4 AEs that are unlikely related or definitely not related to treatment. If the adverse event met the definition of a serious adverse event, it was collected regardless of attribution.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Waters, MD
Washington University School of Medicine
Phone: 314-747-7236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place