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

Primary Purpose

Non Small Cell Lung Cancer, Interstitial Lung Disease

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Stereotactic Ablative Radiotherapy

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Stereotactic, Ablative, Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Alberta Health Services, Cross Cancer Institude
London Regional Cancer Program of the Lawson Health Research Institute
Sunnybrook Health Sciences Centre
UHN Princess Margaret Cancer Centre
CHUM Université de Montréal
Edinburgh Cancer Centre, Western General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm: Stereotactic Ablative Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Survival

Time from enrollment to death from any cause

Secondary Outcome Measures

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

Progression-Free Survival

Local Control as determined via radiographic evidence

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

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.

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

Rates of Acute-Exacerbation of ILD

Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire

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.

Changes in ILD Severity measured by High Resolution Computed Tomography (HRCT)

Changes in Pulmonary Function Tests

Exploratory Quantitative Analysis of High Resolution Computed Tomography (HRCT) Features

Analysis of Outcomes for Patients Eligible for Study Who Decline Radiotherapy

Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire

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.

Full Information

NCT ID

NCT03485378

First Posted

March 7, 2018

Last Updated

March 7, 2023

Sponsor

Lawson Health Research Institute

Collaborators

London Health Sciences Centre, University of British Columbia, Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT03485378

Brief Title

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

Acronym

ASPIRE-ILD

Official Title

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 20, 2018 (Actual)

Primary Completion Date

September 20, 2023 (Anticipated)

Study Completion Date

September 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

Collaborators

London Health Sciences Centre, University of British Columbia, Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer, Interstitial Lung Disease

Keywords

Stereotactic, Ablative, Radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm: Stereotactic Ablative Radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Ablative Radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time from enrollment to death from any cause

Time Frame

4 years

Secondary Outcome Measure Information:

Title

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

Time Frame

8 years

Title

Progression-Free Survival

Time Frame

8 years

Title

Local Control as determined via radiographic evidence

Time Frame

8 years

Title

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

Description

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.

Time Frame

8 years

Title

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

Time Frame

8 years

Title

Rates of Acute-Exacerbation of ILD

Time Frame

8 years

Title

Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire

Description

Time Frame

8 years

Title

Changes in ILD Severity measured by High Resolution Computed Tomography (HRCT)

Time Frame

8 years

Title

Changes in Pulmonary Function Tests

Time Frame

8 years

Title

Exploratory Quantitative Analysis of High Resolution Computed Tomography (HRCT) Features

Time Frame

8 years

Title

Analysis of Outcomes for Patients Eligible for Study Who Decline Radiotherapy

Time Frame

8 years

Title

Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire

Description

Time Frame

8 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Palma, MD

Organizational Affiliation

London Health Sciences Centre, Lawson Health Research Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alexander Louie, MD

Organizational Affiliation

London Health Sciences Centre, Lawson Health Research Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Chris Ryerson, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Chair

Facility Information:

Facility Name

Alberta Health Services, Cross Cancer Institude

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

London Regional Cancer Program of the Lawson Health Research Institute

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

UHN Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

CHUM Université de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Edinburgh Cancer Centre, Western General Hospital

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31829203

Citation

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.

Results Reference

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Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

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