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Proton Beam Therapy

Precision Radiotherapy for Non-Small Cell Lung Cancer (ASPIRE-ILD Trial)

N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Stage T1-2, N0, M0 (AJCC Staging, 8th Edition - i.e. tumor size ≤ 5 cm) prior to registration
Must not have
Concurrent administration of any drugs with known radiosensitive effects (e.g. Methotrexate)
Plans for the patient to receive other local therapy while on this study, except at disease progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new cancer treatment in patients with Non-Small Cell Lung Cancer and Interstitial Lung Disease. Outcomes will be measured based on how well the treatment works and how safe it is.

Who is the study for?
This trial is for adults over 18 with early-stage Non-Small Cell Lung Cancer (NSCLC) and Interstitial Lung Disease (ILD). They should not be candidates for surgery, have a life expectancy of more than 6 months, and an ECOG performance status of 0-3. Excluded are those with other recent cancers, prior thoracic radiotherapy, or taking certain drugs that affect radiotherapy.
What is being tested?
The study tests Stereotactic Ablative Radiotherapy (SABR) on NSCLC patients with ILD to see its effectiveness and safety. Participants are grouped based on their ILD-GAP index to assess outcomes specific to their condition's severity.
What are the potential side effects?
Potential side effects include typical radiation-related issues such as skin irritation at the treatment site, fatigue, shortness of breath, chest pain, coughing up blood, and possible worsening of lung function due to pre-existing ILD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do heavy physical work.
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My cancer is early stage, with a tumor size of 5 cm or less and hasn't spread.
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I am 18 years old or older.
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I have been diagnosed with a type of lung scarring by a lung specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications known to increase sensitivity to radiation.
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I plan to only receive the study treatment unless my disease gets worse.
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I have had radiation therapy to the chest area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Cough Severity as reported by the participant via 10 cm analogue Cough Severity Scale
Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire
Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment Arm: Stereotactic Ablative RadiotherapyExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease

Find a Location

Who is running the clinical trial?

Western University, CanadaOTHER
252 Previous Clinical Trials
58,453 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,894 Total Patients Enrolled
London Health Sciences CentreOTHER
146 Previous Clinical Trials
52,315 Total Patients Enrolled

Media Library

Stereotactic Ablative Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03485378 — N/A
Interstitial Lung Disease Research Study Groups: Treatment Arm: Stereotactic Ablative Radiotherapy
Interstitial Lung Disease Clinical Trial 2023: Stereotactic Ablative Radiotherapy Highlights & Side Effects. Trial Name: NCT03485378 — N/A
Stereotactic Ablative Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03485378 — N/A
~5 spots leftby Nov 2025
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