- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528942
Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
July 21, 2021 updated by: University of Colorado, Denver
Early Phase Clinical Trial 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
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
-
-
Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
-
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Michigan
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Royal Oak, Michigan, United States, 48085
- Beaumont Health System
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-
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:
- 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)
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Radiation therapy
The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator.
Patients will receive daily radiation treatment for 15-35 days.
|
Radiation therapy will be given to study patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yevgeniy Vinogradskiy, PhD, University of Colorado, Denver
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.
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 (ACTUAL)
April 22, 2016
Primary Completion (ACTUAL)
January 25, 2021
Study Completion (ACTUAL)
January 25, 2021
Study Registration Dates
First Submitted
August 6, 2015
First Submitted That Met QC Criteria
August 18, 2015
First Posted (ESTIMATE)
August 19, 2015
Study Record Updates
Last Update Posted (ACTUAL)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 21, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-1856.cc
- 1R01CA200817-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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