Non-small Cell Lung CancerPhase 2FLAIRNCT02002052
Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial
A Phase 2 study testing Concurrent platinum-based chemotherapy, Standard Radiotherapy, 60 Gy in 30 fractions. and Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions in people with Non-small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Concurrent platinum-based chemotherapy, Standard Radiotherapy, 60 Gy in 30 fractions. and Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Concurrent platinum-based chemotherapy, Standard Radiotherapy, 60 Gy in 30 fractions., Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions
- Keywords
- non-small cell lung cancer, radiotherapy, chemotherapy, pneumonitis, functional lung avoidance
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent platinum-based chemotherapyDrug
Platinum-based concurrent chemotherapy in both arms
Standard Radiotherapy, 60 Gy in 30 fractions.Radiation
Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractionsRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions Receives: Drug: Concurrent platinum-based chemotherapy; Radiation: Standard Radiotherapy, 60 Gy in 30 fractions. |
| Experimental Arm | Experimental | Functional-lung avoidance radiotherapy, total dose 60 Gy in 30 fractions, with concurrent platinum-based chemotherapy Receives: Drug: Concurrent platinum-based chemotherapy; Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary quality of life 3-months post-treatment.
Measured using the Functional-Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
Measured: 3-months post-treatment
Secondary outcomes (5)
Quality of life at other time points
Measured using the FACT-LCS, FACT-TOI, and FACT-L
Measured: up to 1 year
Toxicity
CTC-AE version 4
Measured: up to 1 yr
Overall Survival
Defined as time from randomization to death from any cause
Measured: 5-years
Progression Free Survival
Time from randomization to disease progression at any site or death
Measured: Up to 5 years
Quality-adjusted survival
Based on utilities from EQ-5D
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Yaremko, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002052
- Sponsor's protocol ID
- UWO-FLAIR
- Acronym
- FLAIR
- Status last verified
- Jan 2018
- First submitted
- 29 Nov 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoover DA, Capaldi DP, Sheikh K, Palma DA, Rodrigues GB, Dar AR, Yu E, Dingle B, Landis M, Kocha W, Sanatani M, Vincent M, Younus J, Kuruvilla S, Gaede S, Parraga G, Yaremko BP. Functional lung avoidance for individualized radiotherapy (FLAIR): study protocol for a randomized, double-blind clinical trial. BMC Cancer. 2014 Dec 11;14:934. doi: 10.1186/1471-2407-14-934.
PubMed 25496482
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02002052
- Acronym / sponsor ID
- FLAIR / UWO-FLAIR
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, radiotherapy, chemotherapy, pneumonitis, functional lung avoidance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 29 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Active comparator | Drug: Concurrent platinum-based chemotherapy, Radiation: Standard Radiotherapy, 60 Gy in 30 fractions.Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions |
| Experimental Arm | Experimental | Drug: Concurrent platinum-based chemotherapy, Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractionsFunctional-lung avoidance radiotherapy, total dose 60 Gy in 30 fractions, with concurrent platinum-based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent platinum-based chemotherapyPlatinum-based concurrent chemotherapy in both arms | Drug | Experimental Arm, Standard Arm |
| Standard Radiotherapy, 60 Gy in 30 fractions. | Radiation | Standard Arm |
| Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions | Radiation | Experimental Arm |
Primary outcome
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)
5 secondary outcomes
Quality of life at other time points
Time frame: up to 1 year
Toxicity
Time frame: up to 1 yr
Overall Survival
Time frame: 5-years
Progression Free Survival
Time frame: Up to 5 years
Quality-adjusted survival
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 25496482Hoover DA, Capaldi DP, Sheikh K, Palma DA, Rodrigues GB, Dar AR, Yu E, Dingle B, Landis M, Kocha W, Sanatani M, Vincent M, Younus J, Kuruvilla S, Gaede S, Parraga G, Yaremko BP. Functional lung avoidance for individualized radiotherapy (FLAIR): study protocol for a randomized, double-blind clinical trial. BMC Cancer. 2014 Dec 11;14:934. doi: 10.1186/1471-2407-14-934.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Yaremko, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent platinum-based chemotherapy, Standard Radiotherapy, 60 Gy in 30 fractions. and Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions in people with Non-small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary quality of life 3-months post-treatment. (time frame: 3-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02002052, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.