NCT03673176

Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy

Completed NA Results posted Last updated 11 July 2024

What this trial tests

NA trial testing Stereotactic Ablative Radiotherapy (SABR) in Emphysema in 9 participants. Completed in 2 August 2021.

Timeline

11 February 2013

Primary endpoint
2 August 2021

2 August 2021

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	11 February 2013
Primary completion	2 August 2021
Estimated completion	2 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Stereotactic Ablative Radiotherapy (SABR)

Conditions studied

• Emphysema — all drugs for Emphysema →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Emphysema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Patients With Grade 3 or Higher Adverse Events. Primary · 18 months

Adverse events will be based upon National Cancer Institute Common Terminology Criteria

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	3

Change From Baseline Value in Forced Expiratory Volume Percent Predicted Secondary · Baseline and months 6, 12, and 18

Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18)

Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	28.5	19.0 – 42.0

Change at 6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	5.0	-3.0 – 18.0

Change at 12 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	3.0	3.0 – 10.0

Change at 18 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	5.5	-2.0 – 6.0

Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) Secondary · Baseline and months 6, 12, and 18

Forced Expiratory Volume will be taken both prior (baseline) and following the procedure (months 6, 12, and 18)

Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	0.79	0.53 – 1.29

Change at 6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	0.13	-0.08 – 0.50

Change at 12 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	0.14	-0.03 – 0.25

Change at 18 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	0.02	-0.06 – 0.15

Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) Secondary · Baseline and months 6, 12, and 18

Diffusing Capacity for Carbon Dioxide will be taken both prior (baseline) and following the procedure (months 6, 12, and 18)

Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	40.0	24.0 – 67.0

Change at 6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	-8.0	-20.0 – 11.0

Change at 12 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	-10.0	-14.0 – 9.0

Change at 18 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	-3.5	-22.0 – 11.0

Change From Baseline in 6 Minute Walk Test (Meters) Secondary · Baseline and month 6

The walk test will be done both prior (baseline) and following the procedure (month 6)

Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	289.0	48.0 – 430.0

6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	406.0	79.0 – 629.0

Change at 6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	27.0	11.0 – 301.0

Total Lung Capacity (% of Predicted Value) Secondary · Baseline and date of last available time-point in follow-up period (up to 18 months)

Total Lung Capacity will be measured both prior (baseline) and following the procedure (up to 18 months)

Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	127.5	117 – 146

Last available time-point in follow-up period

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	119.5	104 – 147

Residual Volume (RV) (% of Predicted Value) Secondary · Baseline and date of last available time-point in follow-up period (up to 18 months)

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

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	191	104 – 255

Last available time-point in follow-up period

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	188	104 – 238

Short Form (SF)-36 Quality of Life Survey Score Secondary · Baseline and months 6

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.

PCS-Baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	31.9	24.1 – 43.8

PCS-6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	24.9	21.1 – 48.6

MCS-baseline

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	48.0	21.0 – 58.3

MCS-6 months

Group	Value	95% CI
Stereotactic Ablative Radiotherapy	51.5	34.6 – 57.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stereotactic Ablative Radiotherapy

Serious: 4/9 (44%)

Deaths: 4/9

Serious adverse events (8 terms)

Reaction	System	Stereotactic Ablative Radi…
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Heart failure	Cardiac disorders	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Heart failure	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Stereotactic Ablative Radi…
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	—
Rib pain	Musculoskeletal and connective tissue disorders	—
Atrial fibrillation	Cardiac disorders	—

Most-reported serious reactions: COPD exacerbation, Pneumonitis, Pleural effusion, Heart failure, Pleural effusion, Heart failure, Atrial fibrillation, Pneumonia.

Data from ClinicalTrials.gov NCT03673176 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.