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)
Overall Survival — 4 years Time from enrollment to death from any cause
Trial sites (6)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.