Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial (FLAIR)
September 23, 2019 updated by: Lawson Health Research Institute
Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%, and is associated with a decline in pulmonary quality of life.
Standard radiation planning aims to optimize dose to the anatomic lung volume, without consideration of the differences in regional lung function. Functional lung avoidance radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead depositing dose in areas of lung that are not well-ventilated. Functional lung regions are determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans. Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs. functional lung avoidance radiotherapy (with concurrent chemotherapy).
Study Overview
Status
Terminated
Conditions
Detailed Description
All consenting patients will undergo hyperpolarized noble gas MRI using 3-He for definition of functional lung volumes.
Two radiotherapy treatment plans will be generated prior to randomization: one standard plan using anatomical lung avoidance, and one functional lung avoidance plan.
After approval of both plans, patients will be randomized, and both patients and physicians will be blinded to treatment allocation.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A4L6
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or older
- Willing to provide informed consent
- ECOG performance status 0-2
- Histologically confirmed non-small cell lung carcinoma
- Locally advanced Stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
- History of at least 10-pack-years of smoking
- Not undergoing surgical resection
- Assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy
Exclusion Criteria:
- Contraindications to MRI
- Serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Metastatic disease. Patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent.
- Inability to attend full course of radiotherapy or follow-up visits
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Arm
Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions
|
Platinum-based concurrent chemotherapy in both arms
|
|
Experimental: Experimental Arm
Functional-lung avoidance radiotherapy, total dose 60 Gy in 30 fractions, with concurrent platinum-based chemotherapy
|
Platinum-based concurrent chemotherapy in both arms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary quality of life 3-months post-treatment.
Time Frame: 3-months post-treatment
|
Measured using the Functional-Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
|
3-months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life at other time points
Time Frame: up to 1 year
|
Measured using the FACT-LCS, FACT-TOI, and FACT-L
|
up to 1 year
|
|
Toxicity
Time Frame: up to 1 yr
|
CTC-AE version 4
|
up to 1 yr
|
|
Overall Survival
Time Frame: 5-years
|
Defined as time from randomization to death from any cause
|
5-years
|
|
Progression Free Survival
Time Frame: Up to 5 years
|
Time from randomization to disease progression at any site or death
|
Up to 5 years
|
|
Quality-adjusted survival
Time Frame: Up to 5 years
|
Based on utilities from EQ-5D
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Yaremko, MD, Lawson Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 29, 2013
First Submitted That Met QC Criteria
November 29, 2013
First Posted (Estimate)
December 5, 2013
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWO-FLAIR
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