Head and Neck CarcinomaPULS-PalNCT06572423
Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
A study testing Personalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy and Computed Tomography in people with Head and Neck Carcinoma and Localized Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Localized Head and Neck Carcinoma, Metastatic Head and Neck Carcinoma
- What is being tested?
- Personalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy and Computed Tomography
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 16 Dec 2029
- Phase
- Interventional
- 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
- >= 18 years old
- Diagnosis of primary or recurrent, localized or metastatic (American Joint Committee on Cancer (AJCC) 8th Edition stages I-IV) head and neck cancer. In primary diagnosis cases, pathologic confirmation is required. In recurrent and/or metastatic diagnosis cases, pathologic confirmation is not required if not beneficial to the patient as standard of care, and diagnosis can be assumed based on clinical and/or radiographic evidence
- Ineligible for or declines standard of care definitive treatment(s), which will be documented in the patient's trial screening progress note in their electronic medical record by the treating physician
- Measurable disease within the head and/or neck clinically and/or on imaging studies (CT, PET, MRI) within 30 days from date of enrollment
- Patient maximum tumor(s) or tumor bed diameter must be less than 10cm
- In a woman of childbearing potential, a negative serum or urine pregnancy test within 1 week of treatment start must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment
- Patients with a tracheostomy and/or a percutaneous endoscopic gastrostomy tube are eligible for inclusion
Who cannot join
- Pregnant or breast-feeding
- More than 1 prior radiation treatment course directed to the treatment area over the patient's lifetime. In patients who have received 1 prior radiation treatment course directed to the treatment area, that prior radiation treatment course must have concluded at least 6 months prior to trial enrollment
- Any comorbidity or condition which would limit full compliance with the protocol
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 California at Los Angeles
Los Angeles, California, 90095
Mili Santoso, 310-267-2153, msantoso@mednet.ucla.edu
Vincent Basehart, 3102678954, vbasehart@mednet.ucla.edu
About this study
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.
Read the detailed description
A significant proportion of patients with de novo or recurrent head and neck cancer are not candidates for standard-of-care definitive treatment(s), including standard-of-care stereotactic body radiation therapy (SBRT). Current palliative radiation therapy regimens result in adequate symptom improvement though with suboptimal local control and/or toxicity. The durability of symptom and local control in these patients is becoming more important as advances in systemic therapy are improving these patients' survival.
After confirmation of eligibility, enrolled patients will undergo radiation simulation and planning per standard of care. HyperArc technology will be used for treatment planning given prior internal validation of its superiority. Dosimetric constraints will be adapted from the available literature as appropriate. Patients will receive an 11 Gray fraction of radiation to the head and neck tumor site every 14 +/-10 days.
It is possible that patients will experience anatomical and/or tumor changes during the radiation therapy course such that patient alignment for radiation therapy is no longer optimized to the original CT simulation and radiation plan. In such cases where it is determined that adaptive planning is needed, the Investigators will abort planned radiation therapy and immediately perform re-simulation and re-planning if the anatomic change is significant enough to put adjacent normal tissue at significant risk; otherwise, the Investigators will re-plan with the next fraction of radiation to minimize treatment delays. This will be determined by the treating physician through standard of care clinical criteria and procedures.
The frequency of re-simulation and adaptive planning as well as associated changes in dosimetry will be measured. Patients will receive 5 PULSAR fractions for a total radiation dose of 55 Gray. Treatment will be terminated early in cases of intolerable treatment-related toxicity, altered clinical context, or the patient declines further treatment.
Enrolled patients are permitted to receive systemic therapy at the discretion of their medical oncologist.
Patient follow-up will be measured from the time of receipt of first PULSAR fraction to 12 months after receipt of the last PULSAR fraction.
- Conditions
- Head and Neck Carcinoma, Localized Head and Neck Carcinoma, Metastatic Head and Neck Carcinoma, Recurrent Head and Neck Carcinoma
- Being tested
- Personalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy, Computed Tomography, Positron Emission Tomography, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized ultrafractionated stereotactic adaptive radiotherapyProcedure or surgery
Also called PULSAR
PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment.
Volume Modulated Arc TherapyRadiation
Also called VMAT, Volumetric Modulated Arc Therapy
Use HyperArc technology
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, CT
Undergo CT simulation for radiation planning
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET Scan, proton magnetic resonance spectroscopic imaging
Undergo PET
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, MRI
Undergo MRI
Best PracticeOther
Also called standard of care
Undergo standard of care
University of Washington Quality of Life Scale, Version 4Behavioural
Also called UW QOL v4
Complete questionnaire
Functional Assessment of Cancer Therapy-Head & NeckBehavioural
Also called FACT Head and Neck Questionnaire, FACT-H&N Questionnaire
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Treatment (PULSAR and HyperArc) | Experimental | Patients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up. Receives: Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy; Radiation: Volume Modulated Arc Therapy; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Other: Best Practice; Behavioral: University of Washington Quality of Life Scale, Version 4; Behavioral: Functional Assessment of Cancer Therapy-Head & Neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression of the treated tumor target
Progression of the treated tumor target will be determined clinically and/or radiographically as applicable. Time to progression of the treated tumor target will be reported descriptively for each patient. One-year treated tumor target progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.
Measured: From baseline up to 1 year
Secondary outcomes (8)
Grade 3 or higher treatment-related toxicity
According to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Will be performed across the whole cohort, as well as separate analysis stratifying patients by Human Papillomavirus/p16 status.
Measured: Within 24 months after treatment completion
Disease progression free survival (PFS)
Disease progression of any type will be determined clinically and/or radiographically as applicable. Time to disease progression will be reported descriptively for each patient. One-year disease progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.
Measured: From enrollment to the first objectively documented disease progression, either in or out of the treated field per radiographic and/or clinical evaluation, or death due to any cause, assessed up to 24 months
Overall survival (OS)
The Kaplan-Meier method will be used to summarize overall survival.
Measured: From enrollment until death due to any cause, assessed up to 24 months.
Longitudinal patient reported outcomes on the University of Washington Quality of Life (UW-QoL) Questionnaire
Represented by changes from baseline in the pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, anxiety, intimacy, fear of cancer recurrence, overall health-related quality of life, and overall quality of life domains. Each domain ranges from 0-100 with higher scores meaning a better outcome. Changes will be analyzed with respect to whether they represent minimally important differences.
Measured: From baseline up to 24 months
Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire
Represented by changes from baseline in the physical well-being, social/family well-being, emotional well-being, functional well-being domains and additional concerns. Each domain has multiple specific questions with a 5 point Likert-type scale for responses. Changes will be analyzed with respect to whether they represent minimally important differences.
Measured: From baseline up to 24 months
Radiation therapy dosimetry
Will be performed on patients included in analysis sets FAS and EAS across the whole cohort, as well as separate analyses stratifying patients by Human Papillomavirus/p16 status.
Measured: through study completion, on average of 24 months
Radiation therapy planning
Frequency of re-simulation and/or adaptive planning required with PULSAR
Measured: through study completion, on average of 24 months
Incidence of adverse events (AE)
Safety analyses will be performed for patients included in analysis set Statistical Analysis Software (SAS)
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start25 Oct 2024
- Primary completion16 Dec 2028 (estimated)
- Study completion16 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Travis Courtney, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572423
- Sponsor's protocol ID
- 24-000663
- Acronym
- PULS-Pal
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Courtney PT, L Santoso M, Savjani RR, K Reddy V, Chai-Ho W, Velez Velez MA, J Wong D, Palodichuk C, Basehart TV, P O'Connell D, Cao M, Telesca D, Chin RK. A phase II study of personalized ultrafractionated stereotactic adaptive radiotherapy for palliative head and neck cancer treatment (PULS-Pal): a single-arm clinical trial protocol. BMC Cancer. 2024 Dec 21;24(1):1564. doi: 10.1186/s12885-024-13303-5.
PubMed 39709372
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy for Palliative Head and Neck Cancer Treatment (PULS-Pal)
- ClinicalTrials.gov ID
- NCT06572423
- Acronym / sponsor ID
- PULS-Pal / 24-000663
- Conditions
- Head and Neck Carcinoma, Localized Head and Neck Carcinoma, Metastatic Head and Neck Carcinoma, Recurrent Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 16 Dec 2028 (estimated)
- Study completion
- 16 Dec 2029 (estimated)
- First posted
- 27 Aug 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.
This trial tests how well personalized ultra fractionated stereotactic adaptive radiotherapy (PULSAR) works together with HyperArc© radiation treatment planning technology for palliative (holistic pain and symptom control) tumor control in patients with primary or recurrent, localized or metastatic head and neck cancer (HNC) who are ineligible for or decline standard of care treatment. Researchers want to evaluate if using HyperArc and PULSAR together will deliver higher, possibly more effective doses, resulting in better tumor control with the same or fewer side effects than smaller routine doses. PULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. HyperArc radiation treatment planning technology is a tool that allows for target dose escalation to tumor tissue while maintaining minimal head and neck organs-at-risk doses compared to other radiation treatment planning software. Undergoing PULSAR and HyperArc technology together may be a safe and effective palliative treatment option for patients with HNC.
Detailed description
A significant proportion of patients with de novo or recurrent head and neck cancer are not candidates for standard-of-care definitive treatment(s), including standard-of-care stereotactic body radiation therapy (SBRT). Current palliative radiation therapy regimens result in adequate symptom improvement though with suboptimal local control and/or toxicity. The durability of symptom and local control in these patients is becoming more important as advances in systemic therapy are improving these patients' survival.
After confirmation of eligibility, enrolled patients will undergo radiation simulation and planning per standard of care. HyperArc technology will be used for treatment planning given prior internal validation of its superiority. Dosimetric constraints will be adapted from the available literature as appropriate. Patients will receive an 11 Gray fraction of radiation to the head and neck tumor site every 14 +/-10 days.
It is possible that patients will experience anatomical and/or tumor changes during the radiation therapy course such that patient alignment for radiation therapy is no longer optimized to the original CT simulation and radiation plan. In such cases where it is determined that adaptive planning is needed, the Investigators will abort planned radiation therapy and immediately perform re-simulation and re-planning if the anatomic change is significant enough to put adjacent normal tissue at significant risk; otherwise, the Investigators will re-plan with the next fraction of radiation to minimize treatment delays. This will be determined by the treating physician through standard of care clinical criteria and procedures.
The frequency of re-simulation and adaptive planning as well as associated changes in dosimetry will be measured. Patients will receive 5 PULSAR fractions for a total radiation dose of 55 Gray. Treatment will be terminated early in cases of intolerable treatment-related toxicity, altered clinical context, or the patient declines further treatment.
Enrolled patients are permitted to receive systemic therapy at the discretion of their medical oncologist.
Patient follow-up will be measured from the time of receipt of first PULSAR fraction to 12 months after receipt of the last PULSAR fraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (PULSAR and HyperArc) | Experimental | Procedure: Personalized ultrafractionated stereotactic adaptive radiotherapy, Radiation: Volume Modulated Arc Therapy, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Procedure: Magnetic Resonance Imaging, Other: Best Practice, Behavioral: University of Washington Quality of Life Scale, Version 4, Behavioral: Functional Assessment of Cancer Therapy-Head & NeckPatients undergo standard of care CT simulation for radiation treatment planning using HyperArc software. 1 week later, patients undergo PULSAR fraction therapy once daily on days 0, 14, 28, 42, and 56. Patients may also undergo Positron Emission Tomography (PET) scan and MRI during follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >= 18 years old
- Diagnosis of primary or recurrent, localized or metastatic (American Joint Committee on Cancer (AJCC) 8th Edition stages I-IV) head and neck cancer. In primary diagnosis cases, pathologic confirmation is required. In recurrent and/or metastatic diagnosis cases, pathologic confirmation is not required if not beneficial to the patient as standard of care, and diagnosis can be assumed based on clinical and/or radiographic evidence
- Ineligible for or declines standard of care definitive treatment(s), which will be documented in the patient's trial screening progress note in their electronic medical record by the treating physician
- Measurable disease within the head and/or neck clinically and/or on imaging studies (CT, PET, MRI) within 30 days from date of enrollment
- Patient maximum tumor(s) or tumor bed diameter must be less than 10cm
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding
- More than 1 prior radiation treatment course directed to the treatment area over the patient's lifetime. In patients who have received 1 prior radiation treatment course directed to the treatment area, that prior radiation treatment course must have concluded at least 6 months prior to trial enrollment
- Any comorbidity or condition which would limit full compliance with the protocol
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 ultrafractionated stereotactic adaptive radiotherapyAlso: PULSARPULSAR is a radiation therapy regimen that uses a limited number of fairly large dose pulses while adjusting to specific anatomic and/or biological changes which may occur during the course of the treatment. | Procedure or surgery | Treatment (PULSAR and HyperArc) |
| Volume Modulated Arc TherapyAlso: VMAT, Volumetric Modulated Arc TherapyUse HyperArc technology | Radiation | Treatment (PULSAR and HyperArc) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, CTUndergo CT simulation for radiation planning | Procedure or surgery | Treatment (PULSAR and HyperArc) |
| Positron Emission TomographyAlso: Medical Imaging, PET, PET Scan, proton magnetic resonance spectroscopic imagingUndergo PET | Procedure or surgery | Treatment (PULSAR and HyperArc) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, MRIUndergo MRI | Procedure or surgery | Treatment (PULSAR and HyperArc) |
| Best PracticeAlso: standard of careUndergo standard of care | Other | Treatment (PULSAR and HyperArc) |
| University of Washington Quality of Life Scale, Version 4Also: UW QOL v4Complete questionnaire | Behavioural | Treatment (PULSAR and HyperArc) |
| Functional Assessment of Cancer Therapy-Head & NeckAlso: FACT Head and Neck Questionnaire, FACT-H&N QuestionnaireComplete questionnaire | Behavioural | Treatment (PULSAR and HyperArc) |
Primary outcome
Time to progression of the treated tumor target
Time frame: From baseline up to 1 year
Progression of the treated tumor target will be determined clinically and/or radiographically as applicable. Time to progression of the treated tumor target will be reported descriptively for each patient. One-year treated tumor target progression free survival will be estimated by the Kaplan-Meier method, descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum), and will consider the competing risk of death.
8 secondary outcomes
Grade 3 or higher treatment-related toxicity
Time frame: Within 24 months after treatment completion
Disease progression free survival (PFS)
Time frame: From enrollment to the first objectively documented disease progression, either in or out of the treated field per radiographic and/or clinical evaluation, or death due to any cause, assessed up to 24 months
Overall survival (OS)
Time frame: From enrollment until death due to any cause, assessed up to 24 months.
Longitudinal patient reported outcomes on the University of Washington Quality of Life (UW-QoL) Questionnaire
Time frame: From baseline up to 24 months
Longitudinal patient reported outcomes on the Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N) Questionnaire
Time frame: From baseline up to 24 months
Radiation therapy dosimetry
Time frame: through study completion, on average of 24 months
Radiation therapy planning
Time frame: through study completion, on average of 24 months
Incidence of adverse events (AE)
Time frame: From baseline up to 24 months
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 5 Feb 2026.
- Derived from this study: PubMed 39709372Courtney PT, L Santoso M, Savjani RR, K Reddy V, Chai-Ho W, Velez Velez MA, J Wong D, Palodichuk C, Basehart TV, P O'Connell D, Cao M, Telesca D, Chin RK. A phase II study of personalized ultrafractionated stereotactic adaptive radiotherapy for palliative head and neck cancer treatment (PULS-Pal): a single-arm clinical trial protocol. BMC Cancer. 2024 Dec 21;24(1):1564. doi: 10.1186/s12885-024-13303-5.
- 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.
Travis Courtney, MD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized ultrafractionated stereotactic adaptive radiotherapy, Volume Modulated Arc Therapy and Computed Tomography in people with Head and Neck Carcinoma and Localized Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer 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 7 inclusion and 3 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 5 Feb 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?
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 Mili Santoso (310 267-2153, msantoso@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression of the treated tumor target (time frame: From baseline up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572423, which also lists 1 linked publication.
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 5 Feb 2026.