Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

Official Title

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial

Summary:

This is a prospective phase II study of Stereotactic Ablative Radiation Therapy (SABR) in patients with Non-Small Cell Lung Cancer (NSCLC) and co-existent Interstitial Lung Disease (ILD), to determine oncologic and toxicity outcomes. Patients will be divided into 3 separate cohorts based on the ILD-GAP index.

Trial Description

Primary Outcome:

• Overall Survival

Secondary Outcome:

• Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
• Progression-Free Survival
• Local Control as determined via radiographic evidence
• Cough Severity as reported by the participant via 10 cm analogue Cough Severity Scale
• Rates of Acute-Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
• Rates of Acute-Exacerbation of ILD
• Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire
• Changes in ILD Severity measured by High Resolution Computed Tomography (HRCT)
• Changes in Pulmonary Function Tests
• Exploratory Quantitative Analysis of High Resolution Computed Tomography (HRCT) Features
• Analysis of Outcomes for Patients Eligible for Study Who Decline Radiation Therapy
• Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire

For patients with ILD and concurrent early-stage lung cancer who are not candidates for surgery, data showing high rates of toxicity have led to a difficult clinical dilemma, since there are few alternate treatment options. The option of delivering no treatment whatsoever, which avoids any risk of treatment-related toxicity, is associated with a high risk of death due to the lung cancer itself.

Stereotactic ablative radiation therapy (SABR) is a newer radiation therapy approach which uses modern radiation therapy planning and targeting technologies to precisely deliver larger, ablative doses of radiation therapy. SABR has been associated with high rates of local control. A major advantage of SABR is that in general, the toxicity profile is very favourable, even in patients with substantial co-morbid conditions.

It is possible that currently-used doses and fractionations of SABR, when given with strict planning criteria to minimize the risk of lung toxicity, have only a modest risk of treatment-related toxicity and represent the best possible approach.

This study will examine SABR versus a historical control of untreated stage I non-small cell lung cancer with Overall survival (OS) as the endpoint. OS was selected as it objectively reflects the potential benefits of treatment (i.e. extended survival), the harms of treatment (grade 5 toxicity), and the natural history of the ILD disease process itself.

View this trial on ClinicalTrials.gov