- To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment with single fraction vs multiple fraction stereotactic body radiotherapy in medically inoperable patients with stage I peripheral non-small cell lung cancer.
- To estimate the 1-year primary tumor control rate in these patients.
- To estimate the 1-year overall survival and disease-free survival rate of these patients.
- To assess FDG-PET standardized uptake value changes as a measure of treatment response and outcomes.
- To determine pulmonary function changes by treatment arm and response.
- To determine the association between biomarkers and primary tumor control and/or ≥ grade 2 radiation pneumonitis.
OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment arms.
- Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT) treatment to the target lesion.
- Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for 4 days.
Blood and tumor tissue samples may be collected for further analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
- Histologically or cytologically confirmed primary non-small cell lung cancer, including one of the following subtypes:
- Squamous cell carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Non-small cell carcinoma not otherwise specified
- Stage T1-2, N0, M0 disease
- Tumor size ≤ 5 cm
- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal uptake on PET scan are considered N0
- Patients with hilar or mediastinal lymph nodes > 1 cm on CT scan or abnormal PET scan (including suspicious but nondiagnostic uptake) are eligible provided directed tissue biopsies of all abnormally identified areas are negative for cancer
- No regional or distant metastases
- Peripherally located tumor
- No primary tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
- No involvement of the central pleura and/or structures of the mediastinum
- Resectable disease
- Patient may have declined surgery after consulting with a thoracic surgeon
- Patient deemed "medically inoperable", in the opinion of an experienced thoracic cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or pulmonologist), due to a severe underlying physiological medical problem that would preclude surgery, including any of the following:
- Baseline forced expiratory volume at one second (FEV1) < 40% predicted
- Postoperative FEV1 < 30% predicted
- Severely reduced diffusion capacity
- Baseline hypoxemia and/or hypercapnia
- Exercise oxygen consumption < 50% predicted
- Severe pulmonary hypertension
- Diabetes mellitus with severe end-stage organ damage
- Severe cerebral, cardiac, or peripheral vascular disease
- Severe chronic heart disease
- Measurable disease
- Zubrod performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,800/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No synchronous primary malignancy or other malignancy within the past 2 years except for any of the following:
- Invasive malignancy that was definitively treated and patient remains disease free for > 3 years with a life expectancy of > 3 years
- Carcinoma in situ
- Early stage skin cancer that was definitively treated
- No active systemic, pulmonary, or pericardial infection
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the lung or mediastinum
- No prior chemotherapy for this lung or mediastinal tumor
- Prior chemotherapy for another invasive malignancy allowed provided it was definitively treated and patient remains disease free for > 3 years
- No prior surgery for this lung or mediastinal tumor
- No other concurrent antineoplastic therapy, including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery
Last updated: 05/13/2013
NCT ID: NCT00960999