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Clinical Trials in Canada / NCT03485378
Active, not recruiting Not applicable

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

NCT03485378 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2018-09-20
Last updated
2025-09-18

Condition(s) studied

Non Small Cell Lung CancerInterstitial Lung Disease

Investigational drug(s) / intervention(s)

Stereotactic Ablative Radiotherapy

Stereotactic Ablative Radiotherapy: Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Stage T1-2, N0, M0 (AJCC Staging, 8th Edition - i.e. tumor size ≤ 5 cm) prior to registration. * Not a candidate for surgical resection, determined by any of the following: * Consultation with a thoracic surgeon * Discussion at Multidisciplinary Team (MDT) rounds with a surgeon present * Patient refusal of surgery * Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer (NSCLC) is not required, but strongly recommended. * If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imaging and/or Fluorodeoxyglucose (FDG) avidity that is strongly suggestive of a primary NSCLC. * Eastern Cooperative Oncology Group (ECOG) performance status 0-3; * Age ≥ 18; * Life expectancy \> 6 months * Fibrotic interstitial lung disease of any subtype, as diagnosed by a respirologist/pulmonologist. Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted. * Prior thoracic radiotherapy * Plans for the patient to receive other local therapy while on this study, except at disease progression; * Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression. Patients are allowed to receive anti-fibrotic agents used in the treatment of IPF or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone), or steroids, if those are part of their current ILD treatment regimen. Other immunosuppressive drugs such as mycophenolate, azathioprine, cyclophosphamide, and rituximab must be stopped for 2 weeks prior and 2 weeks after treatment. * Active pregnancy * Concurrent administration of any drugs with known radiosensitive effects (e.g. Methotrexate).

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Alberta Health Services, Cross Cancer Institude Edmonton Alberta
London Regional Cancer Program of the Lawson Health Research Institute London Ontario
Sunnybrook Health Sciences Centre Toronto Ontario
UHN Princess Margaret Cancer Centre Toronto Ontario
CHUM Université de Montréal Montreal Quebec
Edinburgh Cancer Centre, Western General Hospital Edinburgh United Kingdom

More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03485378 on ClinicalTrials.gov ↗ ← All trials in Canada