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Completed

NCT Number: NCT02528942

Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Cancer Center, Aurora, Colorado, United States

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About this study

This study plans to learn more about radiation therapy. Radiation therapy is one of the main treatments used to treat lung cancer. One of the known side effects of this radiation therapy is scarring of the lungs and reduced lung function that can result in shortness of breath. At this time the radiation treatment plan does not take into account differences in lung function between one part of the lung and another. Studies have shown that lung function can vary substantially throughout the lungs. This study aims to plan the radiation therapy to be away from the highest functioning portions of lungs while still delivering the intended radiation dose to the tumor. This study will allow researchers to determine whether taking lung function information into account when designing radiation treatment plans can protect lung function after radiation therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
  • Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
  • 18 years of age or older
  • Signed informed consent
  • Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
  • The patient's 4DCT-ventilation image meets image heterogeneity criteria

Exclusion criteria

  • Patients receiving Stereotactic Body Radiation Therapy
  • Patient receiving palliative radiation therapy (defined as less than 45 Gy)

Treatment and study plan

radiation therapy

Radiation

Radiation therapy will be given to study patients.

Primary outcomes

  1. Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System

    Time frame: Up to 14 months

    To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.

Secondary outcomes

  1. Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance

    Time frame: Up to 14 months

    The percentage will be calculated by taking the ratio of patients that had lung function profiles suitable for functional avoidance and patients that were clinically eligible (receiving 45-75 Gy).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Early Phase Clinical Trial Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2015
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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