RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.
OBJECTIVES: * Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph node sampling improves overall survival of patients with N0 or non-hilar N1 non-small cell lung cancer undergoing resection. * Compare these two methods with reference to identification of occult mediastinal lymph node involvement. * Compare the effect of these two methods on operative time and duration of postoperative complications, including chest tube drainage and length of hospitalization for these patients. * Compare the effect of these two methods on local recurrence free survival and local regional recurrence free survival of these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,023
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Overall survival
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 5 years
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Stanford University Medical Center
Stanford, California, United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States
Shands Cancer Center at the University of Florida
Gainesville, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
...and 64 more locations