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

Not Applicable

Completed

• Conditions: Lung Neoplasms; Lung Cancer
• Interventions: Radiation: Radiation therapy

• Registration Number: NCT02528942
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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 Timeline

• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2016-04-22
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25
• Results First Submitted: 2021-06-03
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Results First Posted: 2021-07-22
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance	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).

Trial Locations

Locations (2)

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Beaumont Health System; 🇺🇸 Royal Oak, Michigan, United States