Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
Lung Cancer
About this trial
This is an interventional diagnostic 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, stage IIIA non-small cell lung cancer, adenocarcinoma of the lung
Eligibility Criteria
Inclusion Criteria: Patient must be ≥ 18 years old. Patient must have ECOG/Zubrod status < 3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration. Patient must be medically fit for surgery. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures. Patient must be available for follow-up. If the patient is a survivor of a prior cancer, all of the following criteria must apply: 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. Exclusion Criteria: Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years. Patient has received prior chemotherapy or radiotherapy for this cancer. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options. Patient for whom the surgeon plans to perform only a wedge resection for treatment.
Sites / Locations
- Providence Cancer Center
- Mobile Infirmary Medical Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Huntington Cancer Center at Huntington Hospital
- University of California Davis Cancer Center
- UCSF Comprehensive Cancer Center
- University of Colorado Health Sciences Center - Denver
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Bayfront Medical Center
- University of Chicago Cancer Research Center
- Alexian Brothers Medical Center
- Cancer Institute at St. John's Hospital
- Southern Illinois University School of Medicine
- Holden Comprehensive Cancer Center at University of Iowa
- Jewish Hospital
- McLaren Regional Cancer Center
- Hurley Medical Center
- William Beaumont Hospital - Royal Oak
- Siteman Cancer Center
- Veterans Affairs Medical Center - Omaha
- Creighton University School of Medicine
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Long Island Cancer Center at Stony Brook University Hospital
- University Hospital at State University of New York - Upstate Medical University
- Comprehensive Cancer Center at Wake Forest University
- Charles M. Barrett Cancer Center at University Hospital
- Ireland Cancer Center
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- Providence Cancer Center at Providence Portland Medical Center
- Cancer Institute at Oregon Health and Science University
- Westmoreland Regional Hospital
- Jameson Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania Medical Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Temple University Hospital
- Allegheny General Hospital
- Western Pennsylvania Hospital
- St. Clair Memorial Hospital
- Lankenau Cancer Center at Lankenau Hospital
- Saint Thomas Hospital
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
- University of Texas - MD Anderson Cancer Center
- Cottonwood Hospital Medical Center
- LDS Hospital
- Cancer Center at the University of Virginia
- Veterans Affairs Medical Center - Seattle
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- West Virginia University Hospitals
- University of Wisconsin Comprehensive Cancer Center
- Medical College of Wisconsin Cancer Center
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
- Cancer Care Ontario-London Regional Cancer Centre
- Toronto General Hospital
Arms of the Study
Arm 1
Experimental
Surgery
All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed. Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.