NCT02002052

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	Concurrent platinum-based chemotherapy	Platinum-based concurrent chemotherapy in both arms
RADIATION	Standard Radiotherapy, 60 Gy in 30 fractions.
RADIATION	Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-12-05
• Last updated: 2019-09-25

Locations

1 site across 1 country: Canada