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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528942
• Other study ID #: 14-1856.cc
• Secondary ID: 1R01CA200817-01
• Status: Completed
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: January 25, 2021

Study information

• Verified date: July 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration

2. Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease

3. 18 years of age or older

4. Signed informed consent

5. Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy

6. The patient's 4DCT-ventilation image meets image heterogeneity criteria

Exclusion Criteria:

1. Patients receiving Stereotactic Body Radiation Therapy

2. Patient receiving palliative radiation therapy (defined as less than 45 Gy)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Radiation therapy
Radiation therapy will be given to study patients.

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Beaumont Health System	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance	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