Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

NCT ID: NCT03485378

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2026-09-20

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 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.

Conditions

Non Small Cell Lung Cancer; Interstitial Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm: Stereotactic Ablative Radiotherapy

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

Group Type: EXPERIMENTAL

Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

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

Interventions

Stereotactic Ablative Radiotherapy

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

Intervention Type: RADIATION

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

David Palma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Palma, MD

Role: STUDY_CHAIR

London Health Sciences Centre, Lawson Health Research Institute

Alexander Louie, MD

Role: STUDY_CHAIR

London Health Sciences Centre, Lawson Health Research Institute

Chris Ryerson, MD

Role: STUDY_CHAIR

University of British Columbia

Locations

Alberta Health Services, Cross Cancer Institude

Edmonton, Alberta, Canada

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

UHN Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CHUM Université de Montréal

Montreal, Quebec, Canada

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, , United Kingdom

Countries

Canada; United Kingdom

References

Palma DA, Bahig H, Hope A, Harrow S, Debenham BJ, Louie AV, Vu TTTT, Filion E, Bezjak A, Campeau MP, Duimering A, Giuliani ME, Laba JM, Lang P, Lok BH, Qu XM, Raman S, Rodrigues GB, Goodman CD, Gaede S, Morisset J, Warner A, Dhaliwal I, Ryerson CJ. Stereotactic Radiation Therapy in Early Non-Small Cell Lung Cancer and Interstitial Lung Disease: A Nonrandomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):575-582. doi: 10.1001/jamaoncol.2023.7269.

Reference Type: DERIVED

PMID: 38451491 (View on PubMed)

Palma DA, Chen H, Bahig H, Gaede S, Harrow S, Laba JM, Qu XM, Rodrigues GB, Yaremko BP, Yu E, Louie AV, Dhaliwal I, Ryerson CJ. Assessment of precision irradiation in early non-small cell lung cancer and interstitial lung disease (ASPIRE-ILD): study protocol for a phase II trial. BMC Cancer. 2019 Dec 11;19(1):1206. doi: 10.1186/s12885-019-6392-8.

Reference Type: DERIVED

PMID: 31829203 (View on PubMed)

Other Identifiers

ASPIRE-ILD

Identifier Type: -

Identifier Source: org_study_id