Lung Volume Reduction for Severe Emphysema by Stereotactic Ablative Radiation Therapy

NCT03673176 | Completed Results DMC

• 1 other identifier: e-protocol 23203
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

• Count of Patients With Grade 3 or Higher Adverse Events.

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

  18 months

Secondary Outcomes (8)

• Change From Baseline Value in Forced Expiratory Volume Percent Predicted

  Baseline and months 6, 12, and 18

• Change From Baseline Value in Forced Expiratory Volume in 1 Second (Liters)

  Baseline and months 6, 12, and 18

• Change From Baseline in Diffusing Capacity for Carbon Dioxide (% Predicted)

  Baseline and months 6, 12, and 18

• Change From Baseline in 6 Minute Walk Test (Meters)

  Baseline and month 6

• Total Lung Capacity (% of Predicted Value)

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

Study Arms (1)

Stereotactic Ablative Radiotherapy

EXPERIMENTAL

Experimental stereotactic ablative radiation treatment

Radiation: Stereotactic Ablative Radiotherapy (SABR)

Interventions

Stereotactic Ablative Radiotherapy (SABR) RADIATION

The prescribed dose will be 45 Gy in three fractions of 15 Gy, on each side that is treated.

Stereotactic Ablative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

Stanford Cancer Center

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 38615887 RESULT

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Shrager, MD
• Organization: Stanford University

shrager@stanford.edu

(650) 721-2086

Study Officials

• Joseph B Shrager, M.D

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chief of thoracic surgery division

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: September 17, 2018
• Study Start: February 11, 2013
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-06

Locations

US (1)