Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

Trial Title: Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

NCT ID: NCT03485378

Condition: Non Small Cell Lung Cancer
Interstitial Lung Disease

Conditions: Official terms:
Lung Diseases
Lung Diseases, Interstitial

Conditions: Keywords:
Stereotactic
Ablative
Radiation

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Stereotactic Ablative Radiotherapy
Description: Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
Arm group label: Treatment Arm: Stereotactic Ablative Radiotherapy

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.

Criteria for eligibility:
Criteria:
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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Alberta Health Services, Cross Cancer Institude

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: London Regional Cancer Program of the Lawson Health Research Institute

Address:
City: London
Zip: N6A 4L6
Country: Canada

Facility:
Name: Sunnybrook Health Sciences Centre

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Facility:
Name: UHN Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: CHUM Université de Montréal

Address:
City: Montréal
Zip: H2X 0A9
Country: Canada

Facility:
Name: Edinburgh Cancer Centre, Western General Hospital

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Start date: September 20, 2018

Completion date: September 20, 2026

Lead sponsor:
Agency: Lawson Health Research Institute
Agency class: Other

Collaborator:
Agency: London Health Sciences Centre
Agency class: Other

Collaborator:
Agency: University of British Columbia
Agency class: Other

Collaborator:
Agency: Western University, Canada
Agency class: Other

Source: Lawson Health Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT03485378