Trial Outcomes & Findings for Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy (NCT NCT03673176)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

18 months

Results posted on

2024-07-11

Participant Flow

9 participants signed consent; 8 were allocated to the study arm.

Participant milestones

Participant milestones
Measure	Stereotactic Ablative Radiotherapy Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Overall Study STARTED	9
Overall Study Received SABR Treatment	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Ablative Radiotherapy Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Overall Study Death prior to intervention	1
Overall Study Death following intervention	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Age, Continuous	73.0 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	8 Participants n=99 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Participants who received SABR

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Count of Patients With Grade 3 or Higher Adverse Events.	3 Participants

SECONDARY outcome

Timeframe: Baseline and months 6, 12, and 18

Population: Participants who received SABR and with data at each respective time point

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Change From Baseline Value in Forced Expiratory Volume Percent Predicted Baseline	28.5 percentage of predicted value Interval 19.0 to 42.0
Change From Baseline Value in Forced Expiratory Volume Percent Predicted Change at 6 months	5.0 percentage of predicted value Interval -3.0 to 18.0
Change From Baseline Value in Forced Expiratory Volume Percent Predicted Change at 12 months	3.0 percentage of predicted value Interval 3.0 to 10.0
Change From Baseline Value in Forced Expiratory Volume Percent Predicted Change at 18 months	5.5 percentage of predicted value Interval -2.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and months 6, 12, and 18

Population: Participants who received SABR and with data at each respective time point

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) Change at 18 months	0.02 liters Interval -0.06 to 0.15
Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) Baseline	0.79 liters Interval 0.53 to 1.29
Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) Change at 6 months	0.13 liters Interval -0.08 to 0.5
Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters) Change at 12 months	0.14 liters Interval -0.03 to 0.25

SECONDARY outcome

Timeframe: Baseline and months 6, 12, and 18

Population: Participants who received SABR and with data at each respective time point

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) Baseline	40.0 percentage of predicted value Interval 24.0 to 67.0
Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) Change at 6 months	-8.0 percentage of predicted value Interval -20.0 to 11.0
Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) Change at 12 months	-10.0 percentage of predicted value Interval -14.0 to 9.0
Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted) Change at 18 months	-3.5 percentage of predicted value Interval -22.0 to 11.0

SECONDARY outcome

Timeframe: Baseline and month 6

Population: Participants with available data

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=6 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Change From Baseline in 6 Minute Walk Test (Meters) Baseline	289.0 meters Interval 48.0 to 430.0
Change From Baseline in 6 Minute Walk Test (Meters) 6 months	406.0 meters Interval 79.0 to 629.0
Change From Baseline in 6 Minute Walk Test (Meters) Change at 6 months	27.0 meters Interval 11.0 to 301.0

SECONDARY outcome

Timeframe: Baseline and date of last available time-point in follow-up period (up to 18 months)

Population: Participants who received SABR and with data at last available time-point in follow-up period

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

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=6 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Total Lung Capacity (% of Predicted Value) Baseline	127.5 percentage of predicted value Interval 117.0 to 146.0
Total Lung Capacity (% of Predicted Value) Last available time-point in follow-up period	119.5 percentage of predicted value Interval 104.0 to 147.0

SECONDARY outcome

Timeframe: Baseline and date of last available time-point in follow-up period (up to 18 months)

Population: Participants who received SABR and with data at last available time-point in follow-up period

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.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Residual Volume (RV) (% of Predicted Value) Baseline	191 percentage of predicted value Interval 104.0 to 255.0
Residual Volume (RV) (% of Predicted Value) Last available time-point in follow-up period	188 percentage of predicted value Interval 104.0 to 238.0

SECONDARY outcome

Timeframe: Baseline and months 6

Population: Participants who received SABR and with data at each respective time point

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.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Radiotherapy n=8 Participants Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Short Form (SF)-36 Quality of Life Survey Score PCS-Baseline	31.9 score on a scale Interval 24.1 to 43.8
Short Form (SF)-36 Quality of Life Survey Score PCS-6 months	24.9 score on a scale Interval 21.1 to 48.6
Short Form (SF)-36 Quality of Life Survey Score MCS-baseline	48.0 score on a scale Interval 21.0 to 58.3
Short Form (SF)-36 Quality of Life Survey Score MCS-6 months	51.5 score on a scale Interval 34.6 to 57.9

SECONDARY outcome

Timeframe: Baseline and months 6, 12, and 18

Population: Data were not collected for this outcome measure

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.

Outcome measures

Outcome data not reported

Adverse Events

Stereotactic Ablative Radiotherapy

Serious events: 4 serious events

Other events: 3 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Stereotactic Ablative Radiotherapy n=9 participants at risk Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	11.1% 1/9 • 18 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 1/9 • 18 months
Cardiac disorders Heart failure	11.1% 1/9 • 18 months
Cardiac disorders Atrial fibrillation	11.1% 1/9 • 18 months
Respiratory, thoracic and mediastinal disorders Pneumonia	11.1% 1/9 • 18 months
Respiratory, thoracic and mediastinal disorders COPD exacerbation	22.2% 2/9 • 18 months

Other adverse events

Other adverse events
Measure	Stereotactic Ablative Radiotherapy n=9 participants at risk Stereotactic Ablative Radiotherapy (SABR): 45 Gy in three fractions of 15 Gy, on each side that is treated.
Musculoskeletal and connective tissue disorders Rib pain	11.1% 1/9 • 18 months
Respiratory, thoracic and mediastinal disorders COPD exacerbation	22.2% 2/9 • 18 months
Cardiac disorders Atrial fibrillation	11.1% 1/9 • 18 months

Additional Information

Joseph Shrager, MD

Stanford University

Phone: (650) 721-2086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place