Lung CancerONE STOPNCT06236516
One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors
A study testing One fraction stereotactic body radiotherapy, HyperSight and Ethos in people with Lung Cancer and Oligometastatic Lung Tumor, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Stereotactic body radiotherapy (SBRT) has become a standard of care for medically inoperable or high-risk operable early-stage non-small cell lung cancer (NSCLC) patients. It is also increasingly used to treat lung metastases in patients with oligometastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Oligometastatic Lung Tumor
- What is being tested?
- One fraction stereotactic body radiotherapy, HyperSight and Ethos
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following diagnoses:
- Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer .
- Clinical AJCC stage I defined as stage 1A1 (T1a1N0M0, T1a tumor less than or equal to 1 cm), stage 1A2 (T1bN0M0, T1b tumor between 1 and 2 cm), and stage 1A3 (T1cN0M0, T1c tumor between 2 and 3 cm).
- Clinical AJCC stage IB defined as T2aN0M0, T2a tumor between 3 and 4 cm.
- Clinical AJCC stage IIA defined as T2bN0M0, T2b tumor between 4 and 5 cm.
- Oligometastatic lung tumor secondary to a primary cancer of any type/histology. Oligometastatic patients may include patients with:
Show all 17Show fewer
- 1-5 sites of metastatic disease with at least one lung lesion intended to be treated with SBRT
- More than 5 sites of metastatic disease with oligo-progressive disease in the lung intended to be treated with SBRT.
- Lesions must be small and peripheral.
- Small is defined as max tumor dimension of 5 cm or less.
- Peripheral is defined as greater than 2 cm from the proximal bronchial tree/mediastinum.
- Tumors and anatomy amenable to one-fraction lung SBRT confirmed by meeting of one-fraction lung SBRT target and constraint metrics on a diagnostic-scan based preplan.
- Patients who do not meet this criterion will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.
- Lesions must have a maximum superior to inferior motion of 1 cm on 4D-CT imaging.
- Patients who do not meet this criteria will be screen fails and triaged to the standard lung SBRT workflow and treated off trial.
- At least 18 years of age.
- Able to understand and willing to sign an IRB approved written informed consent.
Who cannot join
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by ONE STOP SBRT.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of ONE STOP SBRT.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors (ONE STOP)
Stereotactic body radiotherapy (SBRT) has become a standard of care for medically inoperable or high-risk operable early-stage non-small cell lung cancer (NSCLC) patients. It is also increasingly used to treat lung metastases in patients with oligometastatic disease. While SBRT is a powerful tool for the treatment of lung tumors, access to specialized treatment can be limited for patients who live far away from a treatment center. Geographic accessibility can be limiting even for patients receiving one fraction lung SBRT, as the typical consult, CT simulation, and one-fraction treatment workflow is typically at least two to three weeks from start to finish, with a minimum of three in-person appointments.
In this study, a high-quality cone beam CT (CBCT) on-board imaging platform (HyperSight; Varian Medical Systems, Palo Alto, CA) will be coupled with advanced motion management and treatment techniques as well as Ethos (Varian Medical Systems, Palo Alto, CA) daily online adaptation to simulation-free workflow for one fraction SBRT. This has the potential to reduce the time it takes a patient to be cured of their lung tumor from two to three weeks to two to three hours. In this novel workflow, patients will undergo telephone/online consent followed by a diagnostic scan-based pre-plan for one fraction SBRT. On the morning of treatment, a brief follow-up appointment will be followed by treatment on the HyperSight/Ethos platform. Patients will be treated using a simulation-free workflow. A HyperSight Thorax Slow protocol CBCT will be acquired for study purposes, and then the patient will be treated with online adaptive CBCT-guided radiotherapy on the Ethos/HyperSight platform. Treatment delivery will take place following contouring and treatment planning. Patients will undergo standard of care simulation imaging in parallel for comparison.
The purpose of this study is to evaluate the feasibility of a ONE fraction Simulation-free Treatment with CT-guided stereotactic adaptive radiotherapy for Oligometastatic and Primary lung tumors (ONE STOP) workflow for patients with small, peripheral primary or oligometastatic lung tumors.
- Conditions
- Lung Cancer, Oligometastatic Lung Tumor
- Being tested
- One fraction stereotactic body radiotherapy, HyperSight, Ethos
- Keywords
- SBRT, Lung cancer, Oligometastatic cancer, Image-guided radiotherapy, Adaptive radiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One fraction stereotactic body radiotherapyRadiation
Also called SBRT
Radiotherapy will consist of one-fraction SBRT using the Ethos linear accelerator and online adaptive treatment planning system.
HyperSightDevice
HyperSight is a novel on-board imaging platform equipped with rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for both simulation and treatment.
EthosDevice
Ethos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| One Fraction SBRT | Experimental | 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. Receives: Radiation: One fraction stereotactic body radiotherapy; Device: HyperSight; Device: Ethos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the ONE STOP Workflow as Measured by the Number of Participants With Successful Completion of the ONE STOP Workflow Through Treatment Delivery
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start26 Feb 2024
- Primary completion15 May 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Pamela Samson, M.D., MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236516
- Sponsor's protocol ID
- 202401015
- Acronym
- ONE STOP
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2024
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Fraction Simulation-Free Treatment With CT-Guided Stereotactic Adaptive Radiotherapy for Patients With Oligometastatic and Primary Lung Tumors (ONE STOP)
- ClinicalTrials.gov ID
- NCT06236516
- Acronym / sponsor ID
- ONE STOP / 202401015
- Conditions
- Lung Cancer, Oligometastatic Lung Tumor
- Keywords
- SBRT, Lung cancer, Oligometastatic cancer, Image-guided radiotherapy, Adaptive radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stereotactic body radiotherapy (SBRT) has become a standard of care for medically inoperable or high-risk operable early-stage non-small cell lung cancer (NSCLC) patients. It is also increasingly used to treat lung metastases in patients with oligometastatic disease. While SBRT is a powerful tool for the treatment of lung tumors, access to specialized treatment can be limited for patients who live far away from a treatment center. Geographic accessibility can be limiting even for patients receiving one fraction lung SBRT, as the typical consult, CT simulation, and one-fraction treatment workflow is typically at least two to three weeks from start to finish, with a minimum of three in-person appointments.
In this study, a high-quality cone beam CT (CBCT) on-board imaging platform (HyperSight; Varian Medical Systems, Palo Alto, CA) will be coupled with advanced motion management and treatment techniques as well as Ethos (Varian Medical Systems, Palo Alto, CA) daily online adaptation to simulation-free workflow for one fraction SBRT. This has the potential to reduce the time it takes a patient to be cured of their lung tumor from two to three weeks to two to three hours. In this novel workflow, patients will undergo telephone/online consent followed by a diagnostic scan-based pre-plan for one fraction SBRT. On the morning of treatment, a brief follow-up appointment will be followed by treatment on the HyperSight/Ethos platform. Patients will be treated using a simulation-free workflow. A HyperSight Thorax Slow protocol CBCT will be acquired for study purposes, and then the patient will be treated with online adaptive CBCT-guided radiotherapy on the Ethos/HyperSight platform. Treatment delivery will take place following contouring and treatment planning. Patients will undergo standard of care simulation imaging in parallel for comparison.
The purpose of this study is to evaluate the feasibility of a ONE fraction Simulation-free Treatment with CT-guided stereotactic adaptive radiotherapy for Oligometastatic and Primary lung tumors (ONE STOP) workflow for patients with small, peripheral primary or oligometastatic lung tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Fraction SBRT | Experimental | Radiation: One fraction stereotactic body radiotherapy, Device: HyperSight, Device: EthosConsenting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- One of the following diagnoses:
- Lesions must be small and peripheral.
- Tumors and anatomy amenable to one-fraction lung SBRT confirmed by meeting of one-fraction lung SBRT target and constraint metrics on a diagnostic-scan based preplan.
- Lesions must have a maximum superior to inferior motion of 1 cm on 4D-CT imaging.
- At least 18 years of age.
Key exclusion criteria (2 listed)
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by ONE STOP SBRT.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of ONE STOP SBRT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One fraction stereotactic body radiotherapyAlso: SBRTRadiotherapy will consist of one-fraction SBRT using the Ethos linear accelerator and online adaptive treatment planning system. | Radiation | One Fraction SBRT |
| HyperSightHyperSight is a novel on-board imaging platform equipped with rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for both simulation and treatment. | Device | One Fraction SBRT |
| EthosEthos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy. | Device | One Fraction SBRT |
Primary outcome
Feasibility of the ONE STOP Workflow as Measured by the Number of Participants With Successful Completion of the ONE STOP Workflow Through Treatment Delivery
Time frame: Day 1
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Samson, M.D., MPHS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One fraction stereotactic body radiotherapy, HyperSight and Ethos in people with Lung Cancer and Oligometastatic Lung Tumor, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the ONE STOP Workflow as Measured by the Number of Participants With Successful Completion of the ONE STOP Workflow Through Treatment Delivery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.