Status:
ACTIVE_NOT_RECRUITING
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
London Health Sciences Centre
University of British Columbia
Conditions:
Non Small Cell Lung Cancer
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 onco...
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 alter...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03485378
Start Date
September 20 2018
End Date
September 20 2026
Last Update
September 18 2025
Active Locations (6)
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1
Alberta Health Services, Cross Cancer Institude
Edmonton, Alberta, Canada, T6G 1Z2
2
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
UHN Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9