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Spots Global Cancer Trial Database for Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

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Trial Identification

Brief Title: 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

Study ID: NCT03485378

Study Description

Brief Summary: This is a prospective phase II study of Stereotactic Ablative Radiotherapy (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.

Detailed Description: 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 radiotherapy (SABR) is a newer radiotherapy approach which uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy. SABR has been associated with high rates of local control. A major advantage of SABR is that in general, the toxicity profile is very favorable, 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Alberta Health Services, Cross Cancer Institude, Edmonton, Alberta, Canada

London Regional Cancer Program of the Lawson Health Research Institute, London, Ontario, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

UHN Princess Margaret Cancer Centre, Toronto, Ontario, Canada

CHUM Université de Montréal, Montréal, Quebec, Canada

Edinburgh Cancer Centre, Western General Hospital, Edinburgh, , United Kingdom

Contact Details

Name: David Palma, MD

Affiliation: London Health Sciences Centre, Lawson Health Research Institute

Role: STUDY_CHAIR

Name: Alexander Louie, MD

Affiliation: London Health Sciences Centre, Lawson Health Research Institute

Role: STUDY_CHAIR

Name: Chris Ryerson, MD

Affiliation: University of British Columbia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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