Clinical trial · Interventional
Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent platinum-based chemotherapy | Drug | — | UNRESOLVED |
| Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions | Radiation | — | UNRESOLVED |
| Standard Radiotherapy, 60 Gy in 30 fractions. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions
- interventionNames
- Drug: Concurrent platinum-based chemotherapy
- Radiation: Standard Radiotherapy, 60 Gy in 30 fractions.
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Functional-lung avoidance radiotherapy, total dose 60 Gy in 30 fractions, with concurrent platinum-based chemotherapy
- interventionNames
- Drug: Concurrent platinum-based chemotherapy
- Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHoover 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. PMID 25496482