- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673176
Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94305
- Stanford Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stereotactic Ablative Radiotherapy
Experimental stereotactic ablative radiation treatment
|
The prescribed dose will be 45 Gy in three fractions of 15 Gy, on each side that is treated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of patients with grade 3 or higher adverse events.
Time Frame: 1.5 years
|
Adverse events will be based upon National Cancer Institute Common Terminology Criteria
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline value in Forced Expiratory Volume in 1 second (liters)
Time Frame: 1.5 years
|
Forced Expiratory Volume will be taken both prior and following the procedure
|
1.5 years
|
Change from baseline in Diffusing Capacity for Carbon Dioxide (% predicted)
Time Frame: 1.5 years
|
Diffusing Capacity for Carbon Dioxide will be measured both prior and following the procedure
|
1.5 years
|
Change from baseline in Total Lung Capacity (liters)
Time Frame: 1.5 years
|
Total Lung Capacity will be measured both prior and following the procedure
|
1.5 years
|
Change from baseline in 6 Minute Walk Test (feet)
Time Frame: 1.5 years
|
The walk test will be done both prior and following the procedure
|
1.5 years
|
Change from baseline in SF 36 Quality of Life Survey Physical Component Summary Score
Time Frame: 1.5 year
|
The Physical Component Summary Score of the SF-36 Survey (range 0-100; higher score reflects better health state)
|
1.5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Joseph B Shrager, M.D, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- e-protocol 23203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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