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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Lung Neoplasms; Lung Cancer

Treatments: Radiation: Radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02528942

1R01CA200817-01 (U.S. NIH Grant/Contract)

14-1856.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

101 participants in 1 patient group

Radiation therapy

Experimental group

Description:

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.

Treatment:

Radiation: Radiation therapy