Cancer, LungEarly Phase 1NCT06712745
Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
A Early Phase 1 study testing Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR) in people with Cancer, Lung and Metastasis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung, Metastasis
- What is being tested?
- Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 30 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years of age.
- Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.
- Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.
- Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.
- Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration.
- Ability to tolerate MRI.
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- All men, as well as women of child-bearing potential* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of consent, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Note: A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Who cannot join
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
- Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
- Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA, 214 648 1836
Sarah.Hardee@UTSouthwestern.edu
About this study
The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.
Read the detailed description
This will be achieved by demonstrating the feasibility of applying adaptive radiation therapy given in PULSAR fractionation and using a 1.5T MR-guided linac system with real-time motion monitoring (Unity, Elekta). The hypothesis is that safety can be improved through: (1) better visualization of tumors, leading to less uncertainty when delineating GTVs; (2) reduced margins for setup, motion, or other sources of uncertainty; and (3) improved normal tissue healing between radiation fractions. To achieve this, we propose a personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) delivery schedule, administering 5 fractions total, given as one fraction every 3 weeks (Fig. 3) and using MRI-guided adaptive treatment planning.
This study is single arm in nature and in the feasibility phase
- Conditions
- Cancer, Lung, Metastasis
- Being tested
- Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)
- Keywords
- lung, central lumg, cancer, metastasis, PULSAR, non small cell lung cancer, NSCLC
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)Radiation
Radiation Therapy Prescription Dose: A dose of 40-50 Gy in 5 fractions prescribed to the PTV will be used for all cases
| Study group | Role | What they receive |
|---|---|---|
| Feasibility | Experimental | Patients treated with PULSAR will undergo treatment over a total duration of 2-5 months with 3-4 weeks between each fraction. PULSAR treatments completed within 6 months will be acceptable if treatment breaks are required. In the event of a complete response between fractions, remaining fractions will be withheld at the discretion of the treating physician. Treatment may also be terminated for selected grade 3 or higher AEs. Treatment may also be terminated for regional or systemic progression detected during the PULSAR treatment interval. Receives: Radiation: Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy- Survivability and response
Rates of overall response will be assessed by RECIST criteria.Efficacy will be compared between PULSAR and historical controls from HILUS using ANOVA and chi-square test.
Kaplan-Meier methods will be used to estimate progression-free survival, time to subsequent SABR, overall survival, clinical benefit rate, time to treatment discontinuation, duration of response, and time to new metastases.
Response duration will be summarized for patients who responded. Descriptive summary statistics such as median and interquartile range (25% and 75% percentiles) will be used.
Measured: 4 years
Secondary outcomes (1)
Change in Tumor Volume
Change in tumor volume will be measured by comparing pre-treatment tumor volume to during-treatment tumor volumes as measured by MRI and will be analyzed using an independent t-test.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start19 Sep 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, LungStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study agent:Stereotactic ablative body radiation (SABR)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Elekta Limited
- Responsible party
- Principal investigator, Kenneth Westover, University of Texas Southwestern Medical Center
- Investigators
- KENNETH WESTOVER, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712745
- Sponsor's protocol ID
- STU-2024-1215
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung
- ClinicalTrials.gov ID
- NCT06712745
- Acronym / sponsor ID
- STU-2024-1215
- Conditions
- Cancer, Lung, Metastasis
- Keywords
- lung, central lumg, cancer, metastasis, PULSAR, non small cell lung cancer, NSCLC
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Elekta Limited
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Dec 2024 (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.
The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.
Detailed description
This will be achieved by demonstrating the feasibility of applying adaptive radiation therapy given in PULSAR fractionation and using a 1.5T MR-guided linac system with real-time motion monitoring (Unity, Elekta). The hypothesis is that safety can be improved through: (1) better visualization of tumors, leading to less uncertainty when delineating GTVs; (2) reduced margins for setup, motion, or other sources of uncertainty; and (3) improved normal tissue healing between radiation fractions. To achieve this, we propose a personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) delivery schedule, administering 5 fractions total, given as one fraction every 3 weeks (Fig. 3) and using MRI-guided adaptive treatment planning.
This study is single arm in nature and in the feasibility phase
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study agent:Stereotactic ablative body radiation (SABR)
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Experimental | Radiation: Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)Patients treated with PULSAR will undergo treatment over a total duration of 2-5 months with 3-4 weeks between each fraction. PULSAR treatments completed within 6 months will be acceptable if treatment breaks are required. In the event of a complete response between fractions, remaining fractions will be withheld at the discretion of the treating physician. Treatment may also be terminated for selected grade 3 or higher AEs. Treatment may also be terminated for regional or systemic progression detected during the PULSAR treatment interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years of age.
- Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.
- Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.
- Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.
- Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration.
Key exclusion criteria (4 listed)
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
- Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
- Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.
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 |
|---|---|---|
| Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR)Radiation Therapy Prescription Dose: A dose of 40-50 Gy in 5 fractions prescribed to the PTV will be used for all cases | Radiation | Feasibility |
Primary outcome
Efficacy- Survivability and response
Time frame: 4 years
Rates of overall response will be assessed by RECIST criteria.Efficacy will be compared between PULSAR and historical controls from HILUS using ANOVA and chi-square test. Kaplan-Meier methods will be used to estimate progression-free survival, time to subsequent SABR, overall survival, clinical benefit rate, time to treatment discontinuation, duration of response, and time to new metastases. Response duration will be summarized for patients who responded. Descriptive summary statistics such as median and interquartile range (25% and 75% percentiles) will be used.
1 secondary outcome
Change in Tumor Volume
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
KENNETH WESTOVER, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Personalized Ultra-fractionated stereotactic ablative radiotherapy (PULSAR) in people with Cancer, Lung and Metastasis, run by University of Texas Southwestern Medical Center 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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SARAH NEUFELD, MS, MBA (214-645-8525, sarah.hardee@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy- Survivability and response (time frame: 4 years). 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 29 Jun 2026.