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

Official Title

Functional Lung Avoidance for Individualized Radiation Therapy (FLAIR): A Randomized, Double-Blind Clinical 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. Standard radiation planning aims to optimize dose to the anatomic lung volume, without consideration of the differences in regional lung function. Functional lung avoidance radiation therapy aims to reduce radiation therapy 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 radiation therapy planning CT scans. Functional lung avoidance radiation therapy has been demonstrated to be feasible, and this trial aims to compare outcomes between standard radiation therapy (with concurrent chemotherapy) vs. functional lung avoidance radiation therapy (with concurrent chemotherapy).

Trial Description

Primary Outcome:

  • Pulmonary quality of life 3-months post-treatment.
Secondary Outcome:
  • Quality of life at other time points
  • Toxicity
  • Overall Survival
  • Progression Free Survival
  • Quality-adjusted survival
All consenting patients will undergo hyperpolarized noble gas MRI using 3-He for definition of functional lung volumes. Two radiation therapy 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society