Early Stage Non-small Cell Lung CancerNCT05785845
Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer
A study testing Computed tomography-guided stereotactic adaptive radiotherapy and ETHOS in people with Early Stage Non-small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Non-small Cell Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Computed tomography-guided stereotactic adaptive radiotherapy and ETHOS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer or mediastinal recurrent non-small cell lung cancer with plans to be treated with definitive intent SBRT alone.
- 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.
- Lesions must be defined as central or ultra-central according to the Hilus-trial13 criteria:
- Central lesions are defined as lesions 1 cm or less from the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi.
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- Ultra-central lesions are defined as lesions touching the trachea, carina, main bronchi, bronchus intermedius, or lobar bronchi. Lesions that touch the esophagus, great vessels, or heart may also be included as ultra-central.
- Tumor coverage is deemed adequate in simulation treatment planning as determined by the treating and study physicians. Specifically, the dose to 98% of the GTV must be greater than 45 Gy.
- Note: patients with inadequate tumor coverage at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care. *In a in silico analysis of these patients, only 1/6 patients screen-failed based on this inclusion criteria.
- Patients should be able to hold their breath for 10 seconds.
- Inoperable disease or patient has refused/declined surgery.
- Deemed medically fit for SBRT by the treating physician.
- At least 18 years of age.
- Zubrod Performance Status 0-2 within 30 days prior to registration.
- Appropriate stage for protocol entry based upon the following minimum diagnostic workup.
- History/physical examination within 30 days prior to registration.
- FDG-PET/CT scan and/or CT chest (with or without contrast) for staging within 60 days prior to registration.
- Adequate bone marrow and hemostasis function determined no more than 30 days prior to registration, defined as follows:
- Platelets ≥ 150,000 cells/mm3
- Hemoglobin ≥ 8 g/dl
- Able to understand and willing to sign an IRB approved written informed consent.
Who cannot join
- Lesions appearing to extend through the bronchial or great vessel walls on CT imaging.
- Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study.
- Patients with a pre-existing, active diagnosis of metastatic cancer.
- Severe, active comorbidity, defined as follows:
- Unstable angina, history of myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
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- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by CT-guided SBRT.
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of the start of 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: A Phase I Trial of Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer
This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity. Online adaptive radiation therapy was until recently only done clinically on an integrated MRI-guided system, but recently, Varian Medical Systems has created a CT-guided radiotherapy machine capable of online adaptive radiotherapy (ETHOS). The vast majority of stereotactic body radiotherapy (SBRT) for early-stage lung cancers is performed on a CT-guided machine rather than an MRI-guided machine, necessitating the evaluation of adaptive radiotherapy using ETHOS in this population. Historically, the non-adaptive, stereotactic treatment of central and ultra-central thoracic disease has been associated with unacceptable rates of grade 3+ toxicity. This has resulted in widespread adoption of a hypofractionated, less ablative 8-15 day treatment courses, with a baseline, one-year grade 3+ toxicity rate of 20%. Use of CT-STAR with daily, CT-guided plan adaptation to carefully spare adjacent organs-at-risk (OAR) in this setting may enable safe delivery of a shorter (5 fraction) and more ablative radiotherapy course.
- Being tested
- Computed tomography-guided stereotactic adaptive radiotherapy, ETHOS
- Keywords
- NSCLC, lung cancer, ultra-central lung cancer, SBRT, IGRT, adaptive radiotherapy, CT-guided radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography-guided stereotactic adaptive radiotherapyRadiation
Also called CT-STAR
Fractions will be delivered on consecutive business days.
ETHOSDevice
ETHOS is a unique ring-gantry CT-guided linear accelerator notable for having an on-board cone beam CT (CBCT) imaging unit with improved definition and resolution to enable target and organ-at-risk contouring. It also has a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) | Experimental | In this study, consenting and eligible patients will receive a prescription dose of 55 Gy in 5 fractions (when possible) delivered on consecutive business days with adaptation based on daily anatomic changes as per clinical standard of care. Receives: Radiation: Computed tomography-guided stereotactic adaptive radiotherapy; Device: ETHOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grade 3 or greater treatment-related toxicity
-Toxicity graded per CTCAE version 5.
Measured: 12 months post-completion of treatment (estimated to be 12 months and 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start10 Apr 2023
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Non-small Cell 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
- 17 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
- NCT05785845
- Sponsor's protocol ID
- 202302003
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05785845
- Acronym / sponsor ID
- 202302003
- Keywords
- NSCLC, lung cancer, ultra-central lung cancer, SBRT, IGRT, adaptive radiotherapy, CT-guided radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy (CT-STAR) to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity. Online adaptive radiation therapy was until recently only done clinically on an integrated MRI-guided system, but recently, Varian Medical Systems has created a CT-guided radiotherapy machine capable of online adaptive radiotherapy (ETHOS). The vast majority of stereotactic body radiotherapy (SBRT) for early-stage lung cancers is performed on a CT-guided machine rather than an MRI-guided machine, necessitating the evaluation of adaptive radiotherapy using ETHOS in this population. Historically, the non-adaptive, stereotactic treatment of central and ultra-central thoracic disease has been associated with unacceptable rates of grade 3+ toxicity. This has resulted in widespread adoption of a hypofractionated, less ablative 8-15 day treatment courses, with a baseline, one-year grade 3+ toxicity rate of 20%. Use of CT-STAR with daily, CT-guided plan adaptation to carefully spare adjacent organs-at-risk (OAR) in this setting may enable safe delivery of a shorter (5 fraction) and more ablative radiotherapy course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) | Experimental | Radiation: Computed tomography-guided stereotactic adaptive radiotherapy, Device: ETHOSIn this study, consenting and eligible patients will receive a prescription dose of 55 Gy in 5 fractions (when possible) delivered on consecutive business days 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 (21 listed)
- Histologically or radiographically diagnosed stage I-IIA (AJCC, 8th ed.) non-small cell lung cancer or mediastinal recurrent non-small cell lung cancer with plans to be treated with definitive intent SBRT alone.
- Lesions must be defined as central or ultra-central according to the Hilus-trial13 criteria:
- Tumor coverage is deemed adequate in simulation treatment planning as determined by the treating and study physicians. Specifically, the dose to 98% of the GTV must be greater than 45 Gy.
- Patients should be able to hold their breath for 10 seconds.
- Inoperable disease or patient has refused/declined surgery.
Key exclusion criteria (10 listed)
- Lesions appearing to extend through the bronchial or great vessel walls on CT imaging.
- Prior or concurrent malignancies, unless the natural history of the prior or concurrent malignancy does not have the potential to interfere with the interpretation of the results of the study.
- Patients with a pre-existing, active diagnosis of metastatic cancer.
- Severe, active comorbidity, defined as follows:
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by CT-guided 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 |
|---|---|---|
| Computed tomography-guided stereotactic adaptive radiotherapyAlso: CT-STARFractions will be delivered on consecutive business days. | Radiation | Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) |
| ETHOSETHOS is a unique ring-gantry CT-guided linear accelerator notable for having an on-board cone beam CT (CBCT) imaging unit with improved definition and resolution to enable target and organ-at-risk contouring. It also has a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy. | Device | Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) |
Primary outcome
Rate of grade 3 or greater treatment-related toxicity
Time frame: 12 months post-completion of treatment (estimated to be 12 months and 5 days)
-Toxicity graded per CTCAE version 5.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- 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 Computed tomography-guided stereotactic adaptive radiotherapy and ETHOS in people with Early Stage Non-small Cell Lung Cancer and Non-small Cell Lung Cancer, 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 21 inclusion and 10 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 6 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of grade 3 or greater treatment-related toxicity (time frame: 12 months post-completion of treatment (estimated to be 12 months and 5 days)). 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 6 Aug 2026.