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| Name | Class |
|---|---|
| Varian, a Siemens Healthineers Company | INDUSTRY |
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Since medical therapies offer only modest palliation and minimal hopes for improved survival to COPD patients, surgical therapies have been designed that may provide greater benefits in selected patients. Lung transplantation, for example, clearly improves survival and quality of life in patients with end stage COPD. This comes at substantial economic cost, however, as well as the at the cost of complications that may result from the complex surgery and from life-long immunosuppression. In addition, nearly all lung transplants will fail within 5 years as a result of progressive bronchiolitis obliterans, which we currently have no way to prevent or treat.
A second operation designed to treat severe COPD patients is lung volume reduction surgery (LVRS). This operation, designed for patients with predominant emphysema rather than chronic bronchitis, is among the most carefully studied operations ever developed.
We believe that by reducing the volume of emphysematous lung with the precise target localization made possible by image-guided SABR, that we will be able to duplicate the benefits of surgical lung volume reduction with far less risk. We believe that this may represent a major advance in the therapy of emphysema - a highly prevalent disease. It may provide not only palliation but also increased survival, as does surgical lung volume reduction, in carefully selected patients.
Stereotactic Ablative Radiotherapy (SABR), also called stereotactic body radiation therapy (SBRT), is a relatively recent advance in radiotherapy which allows high doses of radiation to be transmitted to focused areas (typically malignancies), allowing higher rates of tumoricidal activity, generally lower complications, and greater convenience for patients since it can be delivered in 1 to just a few sessions. As the radiation is administered from multiple directions according to stereotactic planning, high doses can be delivered to the tissues with rapid fall-off to relatively low doses in even nearby, surrounding normal tissues. This technique was initially applied to brain tumors- an application which over the years has met with great success. More recently, it has been applied with substantial success and is gaining increasing acceptance as a primary mode of therapy for stage I lung malignancies, and malignancies in multiple other body areas.
In the lung, the rate of pneumonitis resulting from SABR is far lower than the rates incurred by conventional external beam radiotherapy. In conventional external beam radiotherapy reported pneumonitis rates range from 13-37% (7), depending on dose and field size. Reported rates of symptomatic pneumonitis after lung SABR are significantly lower and generally are ~5% (8). SABR does, however, typically leave a scar in the area of lung that has been treated (9). Importantly, there appears to be contraction of surrounding lung parenchyma into this scar resulting in an effect that is essentially a "lung volume reduction." One often sees clear loss of lung volume following any form of lung radiotherapy. With SABR, this "volume reduction" is achieved with a far lower risk of morbidity - in particular, less risk of pneumonitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablative Radiotherapy | Experimental | Experimental stereotactic ablative radiation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) | Radiation | The prescribed dose will be 45 Gy in three fractions of 15 Gy, on each side that is treated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Patients With Grade 3 or Higher Adverse Events. | Adverse events will be based upon National Cancer Institute Common Terminology Criteria | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Value in Forced Expiratory Volume Percent Predicted | Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) | Baseline and months 6, 12, and 18 |
| Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) |
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Inclusion Criteria:
Pulmonary Function:
Severe COPD with severe reduction in quality of life due to dyspnea
Moderate to Severe emphysematous destruction of lung parenchyma on chest CT
Arterial Blood Gas:
General:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph B Shrager, M.D | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38615887 | Result | Kamtam DN, Binkley MS, Kapula N, Sadeghi C, Nesbit S, Guo HH, Chang J, Maxim PG, Diehn M, Loo BW Jr, Shrager JB. First in Human Phase 1 Clinical Trial of Stereotactic Irradiation to Achieve Lung Volume Reduction (SILVR) in Severe Emphysema. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):345-356. doi: 10.1016/j.ijrobp.2024.03.049. Epub 2024 Apr 12. |
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9 participants signed consent; 8 were allocated to the study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Ablative Radiotherapy | Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who received SABR
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Ablative Radiotherapy | Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Count of Patients With Grade 3 or Higher Adverse Events. | Adverse events will be based upon National Cancer Institute Common Terminology Criteria | Participants who received SABR | Posted | Count of Participants | Participants | 18 months |
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18 months
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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 | Stereotactic Ablative Radiotherapy | Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Possibly related to treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Related to treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Shrager, MD | Stanford University | (650) 721-2086 | shrager@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2017 | Apr 25, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) |
| Baseline and months 6, 12, and 18 |
| Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) | Diffusing Capacity for Carbon Dioxide will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) | Baseline and months 6, 12, and 18 |
| Change From Baseline in 6 Minute Walk Test (Meters) | The walk test will be done both prior (baseline) and following the procedure (month 6) | Baseline and month 6 |
| Total Lung Capacity (% of Predicted Value) | Total Lung Capacity will be measured both prior (baseline) and following the procedure (up to 18 months) | Baseline and date of last available time-point in follow-up period (up to 18 months) |
| Residual Volume (RV) (% of Predicted Value) | Residual volume (RV) is the volume of air remaining in the lungs after maximum forceful expiration. In other words, it is the volume of air that cannot be expelled from the lungs, thus causing the alveoli to remain open at all times. | Baseline and date of last available time-point in follow-up period (up to 18 months) |
| Short Form (SF)-36 Quality of Life Survey Score | The SF-36 Physical Component Summary (PCS) assesses limitations in physical functioning due to health problems, limitations in usual role because of physical health problems, bodily pain, and general health perceptions; the mental component summary (MCS) assesses vitality, limitations in social functioning because of physical or emotional problems, limitations in usual role due to emotional problems, and general mental health. The PCS and MCS scores each range from 0 (worst) to 100 (best). Increases from baseline indicate improvement. | Baseline and months 6 |
| Modified Borg Dyspnea Scale | This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein "0" indicates no difficulty breathing, and "10" indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates "very, very slight (just noticeable) difficulty in breathing." A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing. | Baseline and months 6, 12, and 18 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change From Baseline Value in Forced Expiratory Volume Percent Predicted | Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) | Participants who received SABR and with data at each respective time point | Posted | Median | Full Range | percentage of predicted value | Baseline and months 6, 12, and 18 |
|
|
|
| Secondary | Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) | Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) | Participants who received SABR and with data at each respective time point | Posted | Median | Full Range | liters | Baseline and months 6, 12, and 18 |
|
|
|
| Secondary | Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) | Diffusing Capacity for Carbon Dioxide will be taken both prior (baseline) and following the procedure (months 6, 12, and 18) | Participants who received SABR and with data at each respective time point | Posted | Median | Full Range | percentage of predicted value | Baseline and months 6, 12, and 18 |
|
|
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| Secondary | Change From Baseline in 6 Minute Walk Test (Meters) | The walk test will be done both prior (baseline) and following the procedure (month 6) | Participants with available data | Posted | Median | Full Range | meters | Baseline and month 6 |
|
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|
| Secondary | Total Lung Capacity (% of Predicted Value) | Total Lung Capacity will be measured both prior (baseline) and following the procedure (up to 18 months) | Participants who received SABR and with data at last available time-point in follow-up period | Posted | Median | Full Range | percentage of predicted value | Baseline and date of last available time-point in follow-up period (up to 18 months) |
|
|
|
| Secondary | Residual Volume (RV) (% of Predicted Value) | Residual volume (RV) is the volume of air remaining in the lungs after maximum forceful expiration. In other words, it is the volume of air that cannot be expelled from the lungs, thus causing the alveoli to remain open at all times. | Participants who received SABR and with data at last available time-point in follow-up period | Posted | Median | Full Range | percentage of predicted value | Baseline and date of last available time-point in follow-up period (up to 18 months) |
|
|
|
| Secondary | Short Form (SF)-36 Quality of Life Survey Score | The SF-36 Physical Component Summary (PCS) assesses limitations in physical functioning due to health problems, limitations in usual role because of physical health problems, bodily pain, and general health perceptions; the mental component summary (MCS) assesses vitality, limitations in social functioning because of physical or emotional problems, limitations in usual role due to emotional problems, and general mental health. The PCS and MCS scores each range from 0 (worst) to 100 (best). Increases from baseline indicate improvement. | Participants who received SABR and with data at each respective time point | Posted | Median | Full Range | score on a scale | Baseline and months 6 |
|
|
|
| Secondary | Modified Borg Dyspnea Scale | This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein "0" indicates no difficulty breathing, and "10" indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates "very, very slight (just noticeable) difficulty in breathing." A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing. | Data were not collected for this outcome measure | Posted | Baseline and months 6, 12, and 18 |
|
|
| 4 |
| 9 |
| 4 |
| 9 |
| 3 |
| 9 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Possibly related to treatment |
|
| Heart failure | Cardiac disorders | Systematic Assessment | Possibly related to treatment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to treatment |
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| Heart failure | Cardiac disorders | Systematic Assessment | Unrelated to treatment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Unrelated to treatment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to treatment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to treatment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated to treatment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Unrelated to treatment |
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| Change at 12 months |
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| Change at 18 months |
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| Change at 12 months |
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| Change at 18 months |
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| Change at 12 months |
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| Change at 18 months |
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| Title | Measurements |
|---|
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| MCS-baseline |
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| MCS-6 months |
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