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

September 23, 2019 updated by: Lawson Health Research Institute

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A4L6
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3-months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life at other time points
Time Frame: up to 1 year
Measured using the FACT-LCS, FACT-TOI, and FACT-L
up to 1 year
Toxicity
Time Frame: up to 1 yr
CTC-AE version 4
up to 1 yr
Overall Survival
Time Frame: 5-years
Defined as time from randomization to death from any cause
5-years
Progression Free Survival
Time Frame: Up to 5 years
Time from randomization to disease progression at any site or death
Up to 5 years
Quality-adjusted survival
Time Frame: Up to 5 years
Based on utilities from EQ-5D
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Brian Yaremko, MD, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

November 29, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWO-FLAIR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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