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| ID | Type | Description | Link |
|---|---|---|---|
| SU-10202011-8537 | Other Identifier | Stanford University | |
| LUN0048 | Other Identifier | OnCore |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limited Primary Non-small Cell Lung Cancer (NSCLC) | Experimental | Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0) |
|
| History of NSCLC | Experimental | Participants with prior history of NSCLC and new limited primary NSCLC lesion(s) |
|
| Advanced Lung Cancer Including Metastatic Lung Cancer | Experimental | Participants with more advanced lung cancer or lung metastases from a variety of different cancers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSABR, 25 Gray in 1 fraction for small peripheral tumors | Radiation | Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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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.
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
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| Name | Affiliation | Role |
|---|---|---|
| Maximilian Diehn, MD, PhD | Stanford University | Principal Investigator |
| Bill Loo, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Cancer Institute | Stanford | California | 94305 | United States | ||
| Swedish Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37707820 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2020 |
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|
| iSABR, 50 Gray in 4 fractions for medium peripheral tumors | Radiation | Radiotherapy procedure for participants with medium peripheral tumors > 10 cc and ≤ 30 cc. |
|
|
| iSABR, 54 Gray in 3 fractions for large peripheral tumors | Radiation | Radiotherapy procedure for participants with large peripheral tumors > 30 cc. |
|
|
| iSABR, 40 Gray in 4 fractions for small central tumors | Radiation | Radiotherapy procedure for participants with small central tumors ≤ 10 cc. |
|
|
| iSABR, 50 Gray in 4 fractions for medium central tumors | Radiation | Radiotherapy procedure for participants with medium central tumors > 10 cc and ≤ 30 cc. |
|
|
| iSABR, 60 Gray in 8 fractions for large central tumors | Radiation | Radiotherapy procedure for participants with large central tumors > 30 cc. |
|
|
| 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. | 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. | 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. | 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. | 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. | 2 years |
| Seattle |
| Washington |
| 98104 |
| United States |
| Princess Margaret Cancer Center | Toronto | Ontario | ON M5G 2M9 | Canada |
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | lesions | 1 year | lesions | lesions |
|
|
| |||||||||||||||||||||||||||
| 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.
| 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. | Posted | Number | participants | 1 year |
| |||||||||||||||||||||||||||||||
| 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. | Data were not collected | Posted | up to 2 years |
| |||||||||||||||||||||||||||||||||
| 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. | Data were not collected | Posted | up to 2 years |
| |||||||||||||||||||||||||||||||||
| 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. | Participants with available data | Posted | Number | participants | up to 2 years |
| |||||||||||||||||||||||||||||||
| 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. | Participants with available data | Posted | Number | participants | 2 years |
| |||||||||||||||||||||||||||||||
| 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. | Participants with available data | Posted | Number | participants | 2 years |
|
Up to 7 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 34 | 84 | 4 | 84 | 52 | 84 |
| EG001 | 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. | 25 | 87 | 3 | 87 | 60 | 87 |
| EG002 | 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. | 34 | 85 | 1 | 85 | 40 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung infection (pneumonia) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteonecrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maximilian Diehn, MD, PhD | Stanford University | 650-725-4783 | diehn@stanford.edu |
| Aug 8, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2018 | May 23, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| 40-49 |
|
| 50-59 |
|
| 60-69 |
|
| 70-79 |
|
| 80-89 |
|
| 90-99 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Unknown or Not Reported |
|
| Japan |
|
|
| 50 Gray in 4 fractions for medium peripheral tumors |
|
|
| 54 Gray in 3 fractions for large peripheral tumors |
|
|
| 40 Gray in 4 fractions for small central tumors |
|
|
| 50 Gray in 4 fractions for medium central tumors |
|
|
| 60 Gray in 8 fractions for large central tumors |
|
|
| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
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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. |
| OG002 | 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. |
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| OG001 |
| 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. |
| OG002 | 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. |
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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.
| OG002 | 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. |
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