A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Maximilian Diehn, MD, PhD
- Heather Wakelee
- Joseph Shrager
- Daniel Sze, MD, PhD
- Billy W. Loo, Jr., MD, PhD, DABR
- Nishita Kothary, MD
- Kathleen Horst, MD
- Quynh-Thu Le, MD
- radiation : CyberKnife Stereotactic Radiosurgery
Phase: Phase 2
Ages Eligible For Study:
1. Patient must be over the age of 18 years 2. Pulmonary nodule with maximum diameter ? 5 cm 3. Histological confirmation of primary NSCLC 4. The following stage of NSCLC patients are eligible: - Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size ? 5 cm) - Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size ? 5 cm) 5. ECOG/Zubrod status of 0, 1 or 2 6. Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate. 7. In order to be considered medically inoperable, the patient must meet at least one major criteria or a minimum of 2 minor criteria as described below: MAJOR CRITERIA: 1. FEV1 < 50% or predicted postoperative FEV1 < 40% 2. DLCO < 50% or predicted postoperative DLCO < 40% 3. Exercise induced maximal exercise oxygen consumption M VO2 < 15 mL/kg/min 4. High-risk cardiac disease: Any one of the following: - Poor left ventricular function (defined as an ejection fraction of <=20%) - Unstable coronary syndromes (unstable angina or severe angina Canadian class III or IV). - Severe valvular disease (critical valvular stenosis), - Recent myocardial infarction (< 1 month), - Significant arrhythmia defined by one of the following: High-grade AV block, Symptomatic ventricular arrhythmias in the presence of underlying heart disease, Supraventricular arrhythmias with uncontrolled ventricular rate MINOR CRITERIA: 1. Age > 75 2. Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) 3. Oxygen requirement (using the Medicare criteria for home oxygen requirements [i.e., room air oxygen saturation of 88% or less]) 4. Resting or exercise arterial pO2 ? 55 mm Hg OR SpO2 ? 88%. 5. pCO2 > 45 mm Hg 6. Congestive heart failure (any three of the following must be documented: dyspnea, peripheral edema, chest x-ray with interstitial edema or cardiomegaly, rales, or congestion) 7. Moderately depressed left ventricular function (defined as an ejection fraction of 21-40% or less) 8. Severe cerebral (with CVA or recent TIA) or severe peripheral vascular disease 9. Diabetes Mellitus with severe organ damage such as ESRD, Blindness, Vascular disease. 10. Severe end organ damage from other causes resulting in ESRD, cirrhosis of the liver or vascular disease 11. FEV1 51%-60% or predicted postoperative FEV1 41-50% 12. DLCO 51-60% or predicted postoperative DLCO 41-50% 13. Modified Medical Research Council Dyspnea Scale ? grade 3 8. Females of child-bearing age must be using a reliable form of birth control. 9. The patient must have a PET-CT scan within 8 weeks of registration. 10. The patient must provide a signed and dated written informed consent PRIOR to registration and prior to undergoing any study-related procedures. 11. The patient must provide written authorization to allow the use and disclosure of their protected health information.