Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD)

  • STATUS
    Recruiting
  • End date
    Sep 20, 2026
  • participants needed
    39
  • sponsor
    Lawson Health Research Institute
Updated on 15 February 2022
ct scan
cancer
lung cancer
pulmonary disease
stereotactic body radiation therapy
interstitial lung disease
lung carcinoma

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.

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.

Details
Condition Non Small Cell Lung Cancer, Interstitial Lung Disease
Treatment Stereotactic Ablative Radiotherapy
Clinical Study IdentifierNCT03485378
SponsorLawson Health Research Institute
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

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)
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