Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer
Brief summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer. Secondary * To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens. * To correlate outcomes and toxicities with imaging and patient and tumor biomarkers. OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT). * Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT. Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting. After completion of study treatment, patients are followed for 5 years.
Interventions
RADIATIONArm 1 stereotactic body radiation therapy
Patients undergo 1 high-dose fraction
RADIATIONArm II stereotactic body radiation therapy
Patients undergo 3 high-dose fractions
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-small cell lung cancer * T1-T2, N0 disease measuring ≤ 5 cm( T3 tumor based on chest wall involvement is Excluded) * Surgically resectable primary disease, however patient evaluated by thoracic oncologist and deemed medically inoperable OR patient refuses surgical resection * Age \>= 18
Exclusion criteria
* Prior thoracic radiation therapy * T2 or T3 tumor greater than 5 cm or T3 tumor based on chest wall involvement * Node positive or metastatic disease * Tumor location within the zone of the proximal bronchial tree. The proximal bronchial tree is defined as the carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi. The zone of the proximal bronchial tree is defined as a volume 2cm in all directions around the proximal bronchial tree. * No other conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy (e.g., unable to lie still and breathe reproducibly) * Pregnant or unwilling to use adequate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AE Grade 3 or Higher Toxicity | 1year | Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse. |
| Overall Survival | 5 years | Median overall survival |
| Correlation Between Blood and Serum Markers and Survival and Toxicity | 4 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 High-dose Fraction SBRT Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).
stereotactic body radiation therapy: Patients undergo 1 high-dose fraction | 49 |
| 3 High-dose Fractions SBRT Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.
stereotactic body radiation therapy: Patients undergo 3 high-dose fractions | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 1 High-dose Fraction SBRT | 3 High-dose Fractions SBRT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical >=65 years | 45 Participants | 40 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Continuous | 76.5 years STANDARD_DEVIATION 7.5 | 74.5 years STANDARD_DEVIATION 8 | 75.5 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 41 Participants | 43 Participants | 84 Participants |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 Participants |
| Sex: Female, Male Male | 22 Participants | 26 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 33 / 49 | 29 / 49 |
| other Total, other adverse events | 38 / 49 | 36 / 49 |
| serious Total, serious adverse events | 2 / 49 | 5 / 49 |
Outcome results
Primary
Correlation Between Blood and Serum Markers and Survival and Toxicity
Time frame: 4 years
Population: Data was not collected for this outcome
Primary
Incidence of AE Grade 3 or Higher Toxicity
Count of patients experiencing at least one grade 3 or higher adverse event. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 is used for assessing the adverse events. High grades AEs are considered worse.
Time frame: 1year
Population: All treated and eligible patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I High-dose Fraction SBRT | Incidence of AE Grade 3 or Higher Toxicity | 24 Participants |
| 3 High-dose Fractions SBRT | Incidence of AE Grade 3 or Higher Toxicity | 26 Participants |
Primary
Overall Survival
Median overall survival
Time frame: 5 years
Population: All treated and eligible patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| I High-dose Fraction SBRT | Overall Survival | 39.0 months |
| 3 High-dose Fractions SBRT | Overall Survival | 38.3 months |