Lung Cancer
Conditions
Keywords
Radiotherapy, Pulmonary Functional Imaging, Computed Tomography (CT), Image Registration, Functional Image-guided Radiotherapy
Brief summary
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
Detailed description
In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.
Interventions
RADIATIONVentilation image-guided radiotherapy
Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR). * Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions. * Concurrent chemotherapy is allowed, but not required. * Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians. * Zubrod performance status ≤2 * Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50 * Patient must be able to provide study specific informed consent prior to study entry.
Exclusion criteria
* Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields. * For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible. * For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system. * Children (\<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy | 12 months | Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Pneumonitis Graded by CTCAE v4.0 | 2 years | Number of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. |
| Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1) | Baseline and 6 months | The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment. |
| Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Baseline and 6 months | The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventilation Image-guided Radiotherapy Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Ventilation Image-guided Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 33 |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
Primary
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventilation Image-guided Radiotherapy | Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy | 5 participants |
Secondary
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.
Time frame: Baseline and 6 months
Population: The number of participants analyzed are smaller than 33 due to missing data (disease progression or patient refusal was the main reason).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ventilation Image-guided Radiotherapy | Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | -10 Percent of predicted DLCO |
| Ventilation Image-guided CFRT | Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | -0.5 Percent of predicted DLCO |
Secondary
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
Time frame: Baseline and 6 months
Population: The number of participants analyzed are smaller than 33 due to missing data (disease progression or patient refusal was the main reason).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ventilation Image-guided Radiotherapy | Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1) | 6 Percent of predicted FEV1 |
| Ventilation Image-guided CFRT | Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1) | -1 Percent of predicted FEV1 |
Secondary
Radiation Pneumonitis Graded by CTCAE v4.0
Number of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventilation Image-guided Radiotherapy | Radiation Pneumonitis Graded by CTCAE v4.0 | 5 participants |