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Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial (FLAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002052
Recruitment Status : Terminated (Insufficient accrual)
First Posted : December 5, 2013
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief 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.

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).


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Concurrent platinum-based chemotherapy Radiation: Standard Radiotherapy, 60 Gy in 30 fractions. Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial
Study Start Date : May 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Arm
Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions
Drug: Concurrent platinum-based chemotherapy
Platinum-based concurrent chemotherapy in both arms

Radiation: Standard Radiotherapy, 60 Gy in 30 fractions.
Experimental: Experimental Arm
Functional-lung avoidance radiotherapy, total dose 60 Gy in 30 fractions, with concurrent platinum-based chemotherapy
Drug: Concurrent platinum-based chemotherapy
Platinum-based concurrent chemotherapy in both arms

Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Quality of life at other time points [ Time Frame: up to 1 year ]
    Measured using the FACT-LCS, FACT-TOI, and FACT-L

  2. Toxicity [ Time Frame: up to 1 yr ]
    CTC-AE version 4

  3. Overall Survival [ Time Frame: 5-years ]
    Defined as time from randomization to death from any cause

  4. Progression Free Survival [ Time Frame: Up to 5 years ]
    Time from randomization to disease progression at any site or death

  5. Quality-adjusted survival [ Time Frame: Up to 5 years ]
    Based on utilities from EQ-5D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002052


Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A4L6
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Brian Yaremko, MD Lawson Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02002052    
Other Study ID Numbers: UWO-FLAIR
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: January 2018
Keywords provided by Lawson Health Research Institute:
non-small cell lung cancer, radiotherapy, chemotherapy, pneumonitis, functional lung avoidance
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms