Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief 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. 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.
Interventions
RADIATIONiSABR, 25 Gray in 1 fraction for small peripheral tumors
Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
RADIATIONiSABR, 50 Gray in 4 fractions for medium peripheral tumors
Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
RADIATIONiSABR, 54 Gray in 3 fractions for large peripheral tumors
Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
RADIATIONiSABR, 40 Gray in 4 fractions for small central tumors
Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
RADIATIONiSABR, 50 Gray in 4 fractions for medium central tumors
Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
RADIATIONiSABR, 60 Gray in 8 fractions for large central tumors
Radiotherapy procedure for participants with large central tumors \> 30 cc.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Successfully Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) to Treat Lung Tumors | up to 2 years | 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. |
| Number of Participants With a Difference in Treatment Delivery Time Using an Optimized Breath-hold Technique During Stereotactic Ablative Radiotherapy (SABR) | up to 2 years | 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. |
| Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 1 year | 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. |
| Number of Participants With Metastasis-free Survival (MFS) | 2 years | 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. |
| Number of Participants With Overall Survival (OS) | 2 years | 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. |
| Number of Participants With Progression-free Survival (PFS) | up to 2 years | 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. |
Countries
Canada, Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc. | 84 |
| History of NSCLC Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc. | 87 |
| Advanced Lung Cancer Including Metastatic Lung Cancer Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc. | 85 |
| Total | 256 |
Baseline characteristics
| Characteristic | History of NSCLC | Limited Primary Non-small Cell Lung Cancer (NSCLC) | Advanced Lung Cancer Including Metastatic Lung Cancer | Total |
|---|---|---|---|---|
| Age, Customized 30-39 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized 40-49 | 1 Participants | 1 Participants | 14 Participants | 16 Participants |
| Age, Customized 50-59 | 0 Participants | 6 Participants | 16 Participants | 22 Participants |
| Age, Customized 60-69 | 28 Participants | 20 Participants | 21 Participants | 69 Participants |
| Age, Customized 70-79 | 30 Participants | 32 Participants | 21 Participants | 83 Participants |
| Age, Customized 80-89 | 25 Participants | 22 Participants | 13 Participants | 60 Participants |
| Age, Customized 90-99 | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 83 Participants | 76 Participants | 74 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 19 Participants | 4 Participants | 18 Participants | 41 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 8 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 4 Participants | 3 Participants | 8 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 68 Participants | 51 Participants | 180 Participants |
| Region of Enrollment Japan | 2 participants | 1 participants | 0 participants | 3 participants |
| Region of Enrollment United States | 85 participants | 83 participants | 85 participants | 253 participants |
| Sex: Female, Male Female | 30 Participants | 34 Participants | 41 Participants | 105 Participants |
| Sex: Female, Male Male | 57 Participants | 50 Participants | 44 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 34 / 84 | 25 / 87 | 34 / 85 |
| other Total, other adverse events | 52 / 84 | 60 / 87 | 40 / 85 |
| serious Total, serious adverse events | 4 / 84 | 3 / 87 | 1 / 85 |
Outcome results
Primary
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.
Time frame: 1 year
Population: In Groups 2 and 3, some participants had more than one lesion treated or analyzed. This explains why the total number of participants across specific outcome rows exceeds the overall number of participants in the arm/group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 25 Gray in 1 fraction for small peripheral tumors | 34 lesions |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium peripheral tumors | 15 lesions |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 54 Gray in 3 fractions for large peripheral tumors | 7 lesions |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 40 Gray in 4 fractions for small central tumors | 8 lesions |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium central tumors | 8 lesions |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 60 Gray in 8 fractions for large central tumors | 5 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 60 Gray in 8 fractions for large central tumors | 2 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 25 Gray in 1 fraction for small peripheral tumors | 70 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 40 Gray in 4 fractions for small central tumors | 14 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium central tumors | 4 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium peripheral tumors | 6 lesions |
| History of NSCLC | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 54 Gray in 3 fractions for large peripheral tumors | 2 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium peripheral tumors | 7 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 54 Gray in 3 fractions for large peripheral tumors | 2 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 60 Gray in 8 fractions for large central tumors | 1 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 40 Gray in 4 fractions for small central tumors | 19 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 25 Gray in 1 fraction for small peripheral tumors | 60 lesions |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors. | 50 Gray in 4 fractions for medium central tumors | 11 lesions |
Secondary
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.
Time frame: up to 2 years
Population: Data were not collected
Secondary
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.
Time frame: up to 2 years
Population: Data were not collected
Secondary
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.
Time frame: 2 years
Population: Participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 25 Gray in 1 fraction for small peripheral tumors | 23 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium peripheral tumors | 9 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 54 Gray in 3 fractions for large peripheral tumors | 4 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 40 Gray in 4 fractions for small central tumors | 4 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium central tumors | 5 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Metastasis-free Survival (MFS) | 60 Gray in 8 fractions for large central tumors | 3 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 60 Gray in 8 fractions for large central tumors | 0 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 25 Gray in 1 fraction for small peripheral tumors | 26 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 40 Gray in 4 fractions for small central tumors | 9 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium central tumors | 3 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium peripheral tumors | 3 participants |
| History of NSCLC | Number of Participants With Metastasis-free Survival (MFS) | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium peripheral tumors | 3 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 60 Gray in 8 fractions for large central tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 40 Gray in 4 fractions for small central tumors | 10 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 25 Gray in 1 fraction for small peripheral tumors | 14 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Metastasis-free Survival (MFS) | 50 Gray in 4 fractions for medium central tumors | 1 participants |
Secondary
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.
Time frame: 2 years
Population: Participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 25 Gray in 1 fraction for small peripheral tumors | 28 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium peripheral tumors | 13 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 54 Gray in 3 fractions for large peripheral tumors | 6 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 40 Gray in 4 fractions for small central tumors | 5 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium central tumors | 5 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Overall Survival (OS) | 60 Gray in 8 fractions for large central tumors | 4 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 60 Gray in 8 fractions for large central tumors | 0 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 25 Gray in 1 fraction for small peripheral tumors | 38 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 40 Gray in 4 fractions for small central tumors | 12 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium central tumors | 4 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium peripheral tumors | 4 participants |
| History of NSCLC | Number of Participants With Overall Survival (OS) | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium peripheral tumors | 6 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 54 Gray in 3 fractions for large peripheral tumors | 2 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 60 Gray in 8 fractions for large central tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 40 Gray in 4 fractions for small central tumors | 15 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 25 Gray in 1 fraction for small peripheral tumors | 34 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Overall Survival (OS) | 50 Gray in 4 fractions for medium central tumors | 7 participants |
Secondary
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.
Time frame: up to 2 years
Population: Participants with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 60 Gray in 8 fractions for large central tumors | 3 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 54 Gray in 3 fractions for large peripheral tumors | 4 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium central tumors | 5 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 25 Gray in 1 fraction for small peripheral tumors | 23 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 40 Gray in 4 fractions for small central tumors | 4 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium peripheral tumors | 9 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 40 Gray in 4 fractions for small central tumors | 9 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium central tumors | 3 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium peripheral tumors | 3 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 60 Gray in 8 fractions for large central tumors | 0 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 25 Gray in 1 fraction for small peripheral tumors | 26 participants |
| History of NSCLC | Number of Participants With Progression-free Survival (PFS) | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 25 Gray in 1 fraction for small peripheral tumors | 14 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium peripheral tumors | 3 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 60 Gray in 8 fractions for large central tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 40 Gray in 4 fractions for small central tumors | 10 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Progression-free Survival (PFS) | 50 Gray in 4 fractions for medium central tumors | 1 participants |
Secondary
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.
Time frame: 1 year
Population: In Groups 2 and 3, some participants had more than one lesion treated or analyzed. This explains why the total number of participants across specific outcome rows exceeds the overall number of participants in the arm/group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 25 Gray in 1 fraction for small peripheral tumors | 19 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium peripheral tumors | 8 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 54 Gray in 3 fractions for large peripheral tumors | 3 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 40 Gray in 4 fractions for small central tumors | 4 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium central tumors | 8 participants |
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 60 Gray in 8 fractions for large central tumors | 4 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 60 Gray in 8 fractions for large central tumors | 1 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 25 Gray in 1 fraction for small peripheral tumors | 31 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 40 Gray in 4 fractions for small central tumors | 9 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium central tumors | 3 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium peripheral tumors | 6 participants |
| History of NSCLC | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 54 Gray in 3 fractions for large peripheral tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium peripheral tumors | 3 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 54 Gray in 3 fractions for large peripheral tumors | 0 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 60 Gray in 8 fractions for large central tumors | 1 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 40 Gray in 4 fractions for small central tumors | 6 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 25 Gray in 1 fraction for small peripheral tumors | 18 participants |
| Advanced Lung Cancer Including Metastatic Lung Cancer | Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors | 50 Gray in 4 fractions for medium central tumors | 4 participants |