Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung
Eligibility Criteria
Inclusion Criteria: A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: Pre-operative: Patient must be ≥18 years of age. Patient must have an ECOG/Zubrod performance status of ≤ 3. Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively. Patient must have pre-operative imaging procedure, CT scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection. Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on the CT of the chest defined as no lymph node > 1 cm in the shortest axis. Patient is a candidate for a complete resection of the carcinoma via pneumonectomy,lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection,as noted in the surgical plan. Patient, or patient's legally acceptable representative, must provide a signed and dated Z0030-specific written informed consent prior to registration and any study-related procedures. If patient is a survivor of a prior cancer, the following criteria are met: Patient has undergone potentially curative therapy for all prior malignancies, No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Intra-operative: Patient with right-sided lesions must have at least nodal stations #2R, 4R, 7 and 10 R examined. If the nodes are found, they must be sampled and proven negative by frozen section. Patient with left-sided lesions must have at least nodal stations #5, 6, 7 and 10L examined. If the nodes are found, they must be sampled and proven negative by frozen section. Any other suspicious mediastinal or hilar nodes must be sampled and proven negative by frozen section. Levels 2, 4 and 7 need not be re-sampled if they were sampled at a mediastinoscopy done within 60 days of thehoracotomy. Exclusion Criteria: A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply: Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling. Patient has T3 or T4 tumor. Patient is having only a wedge resection performed for treatment. Patient has received prior chemotherapy or radiotherapy for this cancer.
Sites / Locations
- Mobile Infirmary Medical Center
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- Huntington Cancer Center at Huntington Hospital
- UCSF Comprehensive Cancer Center
- Stanford University Medical Center
- Veterans Affairs Medical Center - Gainesville
- Shands Cancer Center at the University of Florida
- Holmes Regional Medical Center
- Jackson Memorial Hospital
- Emory University School of Medicine
- Medical Center of Central Georgia
- University of Chicago Cancer Research Center
- Alexian Brothers Medical Center
- Loyola University Medical Center
- Edward Hospital Cancer Center
- St. John's Hospital
- Southern Illinois University School of Medicine
- Central Baptist Hospital
- Jewish Hospital
- Medical Center of Southwest Louisiana
- Massachusetts General Hospital Cancer Center
- Rhode Island Hospital
- Beth Israel Deaconess Medical Center
- Hurley Medical Center
- William Beaumont Hospital - Royal Oak
- St. Luke's Hospital
- Veterans Affairs Medical Center - Minneapolis
- Mayo Clinic Cancer Center
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Barnes-Jewish Hospital
- Veterans Affairs Medical Center - Omaha
- Creighton University School of Medicine
- Englewood Hospital Oncology Program
- Valley Hospital
- Roswell Park Cancer Institute
- Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Long Island Cancer Center at Stony Brook University Hospital
- Trinity Hospital
- Veterans Affairs Medical Center - Cincinnati
- Tri-Health Good Samaritan Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Ireland Cancer Center
- Earle A. Chiles Research Institute at Providence Portland Medical Center
- Westmoreland Regional Hospital
- Jameson Memorial Hospital
- Abramson Cancer Center at University of Pennsylvania Medical Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Temple University Hospital
- Allegheny General Hospital
- University of Pittsburg Medical Center - Shadyside Hospital
- Presbyterian-University Hospital
- UPMC St. Margaret
- Western Pennsylvania Hospital
- St. Clair Memorial Hospital
- Lankenau Cancer Center at Lankenau Hospital
- Saint Thomas Hospital
- University of Texas - MD Anderson Cancer Center
- LDS Hospital
- Cancer Center at the University of Virginia
- Massey Cancer Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University of Washington Medical Center
- Veterans Affairs Medical Center - Seattle
- West Virginia University Hospitals
- University of Wisconsin Comprehensive Cancer Center
- Peter MacCallum Cancer Centre
- St. Vincent's Hospital
- Cancer Care Ontario-London Regional Cancer Centre
- Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lymph node sampling
Lymph node dissection
Patients undergo pulmonary resection. No additional lymph nodes are removed. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.
Patients undergo removal of nearly all of the lymph nodes from the central part of the chest between the lungs, followed by pulmonary resection. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.