- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485378
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD)
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Alberta Health Services, Cross Cancer Institude
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- UHN Princess Margaret Cancer Centre
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Quebec
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Montréal, Quebec, Canada, H2X 0A9
- CHUM Université de Montréal
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Edinburgh, United Kingdom, EH4 2XU
- Edinburgh Cancer Centre, Western General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm: Stereotactic Ablative Radiotherapy
Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
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Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 4 years
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Time from enrollment to death from any cause
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: 8 years
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8 years
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Progression-Free Survival
Time Frame: 8 years
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8 years
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Local Control as determined via radiographic evidence
Time Frame: 8 years
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8 years
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Cough Severity as reported by the participant via 10 cm analogue Cough Severity Scale
Time Frame: 8 years
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Cough severity will be reported by participants via a scale, where a score of 100 is no cough and a score of 0 is the worst cough ever.
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8 years
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Rates of Acute-Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
Time Frame: 8 years
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8 years
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Rates of Acute-Exacerbation of ILD
Time Frame: 8 years
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8 years
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Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire
Time Frame: 8 years
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The Functional Assessment of Cancer Therapy - Lung (FACT-L ) is a standardized questionnaire used to measure quality of life.
The questionnaire consists of 5 scales measuring 37 items in total.
Categories of the 5 scales are: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns related to symptoms, cognitive function, and regret of smoking.
The score for each item in the scale ranges from 0 to 4, where 0 is not at all and 4 is very much.
The scores from each scale are added up, and can be combined to provide a total score.
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8 years
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Changes in ILD Severity measured by High Resolution Computed Tomography (HRCT)
Time Frame: 8 years
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8 years
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Changes in Pulmonary Function Tests
Time Frame: 8 years
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8 years
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Exploratory Quantitative Analysis of High Resolution Computed Tomography (HRCT) Features
Time Frame: 8 years
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8 years
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Analysis of Outcomes for Patients Eligible for Study Who Decline Radiotherapy
Time Frame: 8 years
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8 years
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Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire
Time Frame: 8 years
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The EQ-5D-5L is a standardized questionnaire used to measure quality of life and health.
The first section includes 5 categories: mobility, self-care, usual activities (e.g.
work, family), pain/discomfort, and anxiety/depression.
Each category contains 5 statements ranging from no problems to extreme problems, where no problems is assigned a code of 1 and extreme problems is assigned a code of 5. Participants are asked to select the statement that best describes their health that day.
No score is generated, rather a 5 digit code is generated based on the response provided, which can then be combined into a data set and interpreted in a variety of ways.
The second section includes a 20 cm analogue scale from 0 to 100, where 100 is the best health ever imagined and 0 is the worst health imagined.
The participant will mark a score on the scale representing the state of their health on that day.
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8 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASPIRE-ILD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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