Lung Cancer, Lung Neoplasms
Conditions
Keywords
Lung cancer, Radiation therapy, 4DCT-ventilation imaging
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.
Interventions
RADIATIONRadiation therapy
Radiation therapy will be given to study patients.
Sponsors
National Cancer Institute (NCI)
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Radiation therapy will be given to study patients. | 67 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet imaging criteria | 9 |
| Overall Study | Lost to Follow-up | 25 |
Baseline characteristics
| Characteristic | Radiation Therapy |
|---|---|
| Age, Continuous | 66 years |
| Karnofsky Performance Scale (KPS) | 90 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 64 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 67 |
| other Total, other adverse events | 8 / 67 |
| serious Total, serious adverse events | 10 / 67 |
Outcome results
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.
Time frame: Up to 14 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy | 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 | 10 Participants |
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).
Time frame: Up to 14 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy | Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance | 9 Participants |