Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Procedure: conventional surgery
- Registration Number
- NCT00003831
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1023
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lymph node sampling conventional surgery 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. Lymph node dissection conventional surgery 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.
- Primary Outcome Measures
Name Time Method Overall survival Up to 5 years
- Secondary Outcome Measures
Name Time Method Disease-free survival Up to 5 years
Trial Locations
- Locations (74)
St. Luke's Hospital
🇺🇸Duluth, Minnesota, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburg Medical Center - Shadyside Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Huntington Cancer Center at Huntington Hospital
🇺🇸Pasadena, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Edward Hospital Cancer Center
🇺🇸Naperville, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Medical Center of Southwest Louisiana
🇺🇸Lafayette, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
William Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Trinity Hospital
🇺🇸Minot, North Dakota, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Westmoreland Regional Hospital
🇺🇸Greensburg, Pennsylvania, United States
Jameson Memorial Hospital
🇺🇸New Castle, Pennsylvania, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UPMC St. Margaret
🇺🇸Pittsburgh, Pennsylvania, United States
Presbyterian-University Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Tri-Health Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Saint Thomas Hospital
🇺🇸Nashville, Tennessee, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Veterans Affairs Medical Center - Omaha
🇺🇸Omaha, Nebraska, United States
Creighton University School of Medicine
🇺🇸Omaha, Nebraska, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Englewood Hospital Oncology Program
🇺🇸Englewood, New Jersey, United States
Veterans Affairs Medical Center - Gainesville
🇺🇸Gainesville, Florida, United States
Shands Cancer Center at the University of Florida
🇺🇸Gainesville, Florida, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸Boston, Massachusetts, United States