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

NCT02002052 | Terminated Phase 2 DMC

• 1 other identifier: UWO-FLAIR
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, radiotherapy, chemotherapy, pneumonitis, functional lung avoidance

Outcome Measures

Primary Outcomes (1)

• Pulmonary quality of life 3-months post-treatment.

  Measured using the Functional-Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)

  3-months post-treatment

Secondary Outcomes (5)

• Quality of life at other time points

  up to 1 year

• Toxicity

  up to 1 yr

• Overall Survival

  5-years

• Progression Free Survival

  Up to 5 years

• Quality-adjusted survival

  Up to 5 years

Study Arms (2)

Standard Arm

ACTIVE COMPARATOR

Standard platinum-based chemoradiotherapy, total radiation dose 60 Gy in 30 fractions

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

Drug: Concurrent platinum-based chemotherapy; Radiation: Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions

Interventions

Concurrent platinum-based chemotherapy DRUG

Platinum-based concurrent chemotherapy in both arms

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A4L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25496482 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pneumonia

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections

Study Officials

• Brian Yaremko, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: May 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 25, 2019

Record last verified: 2018-01

Locations

CA (1)