Stage I Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological confirmation of non-small cell cancer will be required by either biopsy or cytology; 2. Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC stage I or II based on only one of the following combinations of TNM staging T1, N0, M0 or T2(=40% predicted, post-operative predicted FEV1>=30% predicted, diffusion capacity >=40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption >=50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease; 4. Patients must be >=18 years of age; 5. The patient's Zubrod performance status must be Zubrod 0-2; 6. Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills; 7. Patients must sign a study-specific consent form8 Patients of child bearing potential should use an effective method of birth control throughout their participation in this study.
Exclusion criteria
Exclusion criteria: 1 Patient with T2 primary tumors >5cm; 2 Direct evidence of regional or distant metastases after appropriate staging studies,or synchronous primary or prior malignancy in the past 2 years other than nonmelanomatous skin cancer or in situ cancer; 3 Previous lung or mediastinal radiotherapy 4 Plans for the patient to receive other concomitant local therapy(including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression; 5 Preganant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 6 Lesions involving the proximal bronchial tree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 or 4 toxicity;3 years overall survival;local recurrence;PFS;Rate of metasis; | — |