Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

NCT03485378 | Active Not Recruiting DMC

• 1 other identifier: ASPIRE-ILD
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 6

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.

Conditions

Non Small Cell Lung Cancer; Interstitial Lung Disease

Keywords

Stereotactic; Ablative; Radiation

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from enrollment to death from any cause

  4 years

Secondary Outcomes (12)

• Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  8 years

• Progression-Free Survival

  8 years

• Local Control as determined via radiographic evidence

  8 years

• Cough Severity as reported by the participant via 10 cm analogue Cough Severity Scale

  8 years

• Rates of Acute-Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)

  8 years

Study Arms (1)

Treatment Arm: Stereotactic Ablative Radiotherapy

EXPERIMENTAL

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

Radiation: Stereotactic Ablative Radiotherapy

Interventions

Stereotactic Ablative Radiotherapy RADIATION

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

Treatment Arm: Stereotactic Ablative Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Health Sciences Centre: collaborator
• University of British Columbia: collaborator
• Western University, Canada: collaborator

Study Sites (6)

Alberta Health Services, Cross Cancer Institude

Edmonton, Alberta, T6G 1Z2, Canada

Location

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

UHN Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38451491 DERIVED

• 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.

  PMID: 31829203 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Palma, MD

  London Health Sciences Centre, Lawson Health Research Institute

  STUDY CHAIR

• Alexander Louie, MD

  London Health Sciences Centre, Lawson Health Research Institute

  STUDY CHAIR

• Chris Ryerson, MD

  University of British Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 2, 2018
• Study Start: September 20, 2018
• Primary Completion: January 11, 2022
• Study Completion (Estimated): September 20, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (5)