Non-small Cell Lung Cancer (NSCLC)NCT01463423
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
A study testing iSABR, 25 Gray in 1 fraction for small peripheral tumors, iSABR, 50 Gray in 4 fractions for medium peripheral tumors and iSABR, 54 Gray in 3 fractions for large peripheral tumors in people with Non-small Cell Lung Cancer (NSCLC), run by Stanford University at 4 sites in 3 countries.
Trial summary
A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- iSABR, 25 Gray in 1 fraction for small peripheral tumors, iSABR, 50 Gray in 4 fractions for medium peripheral tumors and iSABR, 54 Gray in 3 fractions for large peripheral tumors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Oct 2011to 7 Feb 2022
- 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
- Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
- Up to 4 lesions may be considered.
- For a single lesion, the sum of three orthogonal diameters can be no more than 20 cm.
- For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.
- Both peripheral and central tumors are accepted for this trial.
- Age ≥ 18 years old
- Patients may be enrolled more than once (eg, for a new tumor lesion)
Who cannot join
- Contraindication for radiotherapy
- Pregnant and breastfeeding women are excluded
- If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Swedish Cancer Institute
Seattle, Washington, 98104
Stanford University Cancer Institute
Stanford, California, 94305
About this study
Official title: Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.
While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, > 10 cc).
This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- iSABR, 25 Gray in 1 fraction for small peripheral tumors, iSABR, 50 Gray in 4 fractions for medium peripheral tumors, iSABR, 54 Gray in 3 fractions for large peripheral tumors, iSABR, 40 Gray in 4 fractions for small central tumors, iSABR, 50 Gray in 4 fractions for medium central tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSABR, 25 Gray in 1 fraction for small peripheral tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with medium peripheral tumors > 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with large peripheral tumors > 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with medium central tumors > 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumorsRadiation
Also called Individualized Stereotactic Ablative Radiotherapy (iSABR)
Radiotherapy procedure for participants with large central tumors > 30 cc.
| Study group | Role | What they receive |
|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Experimental | Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) Receives: Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors; Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors; Radiation: iSABR, 40 Gray in 4 fractions for small central tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors |
| History of NSCLC | Experimental | Participants with prior history of NSCLC and new limited primary NSCLC lesion(s) Receives: Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors; Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors; Radiation: iSABR, 40 Gray in 4 fractions for small central tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Experimental | Participants with more advanced lung cancer or lung metastases from a variety of different cancers. Receives: Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors; Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors; Radiation: iSABR, 40 Gray in 4 fractions for small central tumors; Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors; Radiation: iSABR, 60 Gray in 8 fractions for large central tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.
Measured: 1 year
Secondary outcomes (6)
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
In concept, toxicity refers to adverse events caused by an intervention, ie, related adverse events. Toxicity will be assessed on the basis of related pulmonary; esophageal; chest wall; skin; vascular; cardiac/pericardial; and neurologic adverse events. Such events may have a number of different preferred terms for the adverse effect. The outcome will be reported as the number of Grade 3 or higher adverse effect events (toxicities), by Common Terminology Criteria for Adverse Events (CTCAE) Body System. The following exceptions apply.
- Gastrointestinal Disorders, Grade 4-5 only
- Atelectasis (collapse of the lung or lobe), Grade 4-5 only
- Grade 3 Hypoxia, only if worse than baseline All deaths related to treatment will be included. The outcome is numbers without dispersion.
Measured: 1 year
Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors
Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Feasibility of this technique will be assessed as the number of patients able to reproduce the optimized breath-hold. The outcome is a number without dispersion.
Measured: up to 2 years
Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR)
Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Utility of this technique will be assessed as the difference in treatment delivery time compared to free-breathing treatment, reported as the median with standard deviation.
Measured: up to 2 years
Number of Participants With Progression-free Survival (PFS)
Progression-free survival (PFS) is a measure of participant survival without disease recurrence, relapse, metastasis, or progression. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without disease progression during that time. The outcome is a number without dispersion.
Measured: up to 2 years
Number of Participants With Metastasis-free Survival (MFS)
Metastasis refers to the ability of cancer cells to break free of a tumor, and migrate to another location in the body and start a new tumor lesion. Metastasis-free survival (MFS) is a measure of participant survival without disease metastasis. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without documented metastasis in that time. The outcome is a number without dispersion.
Measured: 2 years
Number of Participants With Overall Survival (OS)
Overall survival (OS) is a measure of participant survival without regard to disease status. The outcome is reported as the number of participants who were documented as alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment. The outcome is a number without dispersion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study start21 Oct 2011
- Primary completion2 Jan 2020
- Study completion7 Feb 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Diehn, Stanford University
- Investigators
- Maximilian Diehn, MD, PhD, Principal investigator, Stanford UniversityBill Loo, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463423
- Sponsor's protocol ID
- IRB-22600
- Other IDs
- SU-10202011-8537, LUN0048
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2011
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gensheimer MF, Gee H, Shirato H, Taguchi H, Snyder JM, Chin AL, Vitzthum LK, Maxim PG, Wakelee HA, Neal J, Das M, Chang DT, Kidd E, Hancock SL, Shultz DB, Horst KC, Le QT, Wong S, Brown E, Nguyen N, Liang R, Loo BW Jr, Diehn M. Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1525-1534. doi: 10.1001/jamaoncol.2023.3495.
PubMed 37707820
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
- ClinicalTrials.gov ID
- NCT01463423
- Acronym / sponsor ID
- IRB-22600
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 21 Oct 2011 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.
While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, > 10 cc).
This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Experimental | Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors, Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors, Radiation: iSABR, 40 Gray in 4 fractions for small central tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors, Radiation: iSABR, 60 Gray in 8 fractions for large central tumorsParticipants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) |
| History of NSCLC | Experimental | Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors, Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors, Radiation: iSABR, 40 Gray in 4 fractions for small central tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors, Radiation: iSABR, 60 Gray in 8 fractions for large central tumorsParticipants with prior history of NSCLC and new limited primary NSCLC lesion(s) |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Experimental | Radiation: iSABR, 25 Gray in 1 fraction for small peripheral tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium peripheral tumors, Radiation: iSABR, 54 Gray in 3 fractions for large peripheral tumors, Radiation: iSABR, 40 Gray in 4 fractions for small central tumors, Radiation: iSABR, 50 Gray in 4 fractions for medium central tumors, Radiation: iSABR, 60 Gray in 8 fractions for large central tumorsParticipants with more advanced lung cancer or lung metastases from a variety of different cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
- Up to 4 lesions may be considered.
- Both peripheral and central tumors are accepted for this trial.
- Age ≥ 18 years old
- Patients may be enrolled more than once (eg, for a new tumor lesion)
Key exclusion criteria (3 listed)
- Contraindication for radiotherapy
- Pregnant and breastfeeding women are excluded
- If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators).
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 |
|---|---|---|
| iSABR, 25 Gray in 1 fraction for small peripheral tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
| iSABR, 50 Gray in 4 fractions for medium peripheral tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with medium peripheral tumors > 10 cc and ≤ 30 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
| iSABR, 54 Gray in 3 fractions for large peripheral tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with large peripheral tumors > 30 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
| iSABR, 40 Gray in 4 fractions for small central tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with small central tumors ≤ 10 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
| iSABR, 50 Gray in 4 fractions for medium central tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with medium central tumors > 10 cc and ≤ 30 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
| iSABR, 60 Gray in 8 fractions for large central tumorsAlso: Individualized Stereotactic Ablative Radiotherapy (iSABR)Radiotherapy procedure for participants with large central tumors > 30 cc. | Radiation | Advanced Lung Cancer Including Metastatic Lung Cancer, History of NSCLC, Limited Primary Non-small Cell Lung Cancer (NSCLC) |
Primary outcome
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
Time frame: 1 year
Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.
6 secondary outcomes
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
Time frame: 1 year
Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors
Time frame: up to 2 years
Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR)
Time frame: up to 2 years
Number of Participants With Progression-free Survival (PFS)
Time frame: up to 2 years
Number of Participants With Metastasis-free Survival (MFS)
Time frame: 2 years
Number of Participants With Overall Survival (OS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37707820Gensheimer MF, Gee H, Shirato H, Taguchi H, Snyder JM, Chin AL, Vitzthum LK, Maxim PG, Wakelee HA, Neal J, Das M, Chang DT, Kidd E, Hancock SL, Shultz DB, Horst KC, Le QT, Wong S, Brown E, Nguyen N, Liang R, Loo BW Jr, Diehn M. Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2023 Nov 1;9(11):1525-1534. doi: 10.1001/jamaoncol.2023.3495.
- 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.
Maximilian Diehn, MD, PhD principal investigator
Stanford University
Bill Loo, MD, PhD principal investigator
Stanford University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSABR, 25 Gray in 1 fraction for small peripheral tumors, iSABR, 50 Gray in 4 fractions for medium peripheral tumors and iSABR, 54 Gray in 3 fractions for large peripheral tumors in people with Non-small Cell Lung Cancer (NSCLC), run by Stanford University at 4 sites in 3 countries.
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: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Japan. 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 19 Dec 2024). 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?
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. (time frame: 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 NCT01463423, 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 19 Dec 2024.