Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/20/2018 |
| Start Date: | February 11, 2013 |
| End Date: | December 30, 2021 |
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 bronchiolotis 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.
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 bronchiolotis 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.
(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.
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
- FEV1 < 45% predicted and >18% predicted
- FEV1/FVC < .7
- DLCO > 18% predicted
- Residual Volume > 160% predicted (by plethysmography)
Arterial Blood Gas:
- paO2>40 on room air at rest
- paCO2<55
General:
- Successful completion of 16 sessions of pulmonary rehabilitation
Exclusion Criteria:
- Predominate chronic bronchitis (none or mild emphysematous destruction of lung on
chest CT).
- Pulmonary function tests / lung volumes that do not meet above criteria.
- Active coronary ischemia (stress test required if clinical symptoms).
- Inability to complete 16 sessions of pulmonary rehabilitation.
- Pregnancy.
- Presence of lung cancer.
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Joseph B Shrager, M.D
Phone: 650-721-2086
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