Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
NCT ID: NCT00003831
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1023 participants
INTERVENTIONAL
1999-07-31
2011-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lymph node sampling
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.
conventional surgery
Lymph node dissection
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.
conventional surgery
Interventions
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conventional surgery
Eligibility Criteria
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Inclusion Criteria
Pre-operative:
1. Patient must be ≥18 years of age.
2. Patient must have an ECOG/Zubrod performance status of ≤ 3.
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.
4. 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.
5. 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.
6. 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.
7. 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.
8. If patient is a survivor of a prior cancer, the following criteria are met:
1. Patient has undergone potentially curative therapy for all prior malignancies,
2. 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),
3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
Intra-operative:
1. 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.
2. 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.
3. 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
1. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
2. Patient has T3 or T4 tumor.
3. Patient is having only a wedge resection performed for treatment.
4. Patient has received prior chemotherapy or radiotherapy for this cancer.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mark S. Allen, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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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
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
Emory University School of Medicine
Atlanta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Edward Hospital Cancer Center
Naperville, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
Medical Center of Southwest Louisiana
Lafayette, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Rhode Island Hospital
Boston, Massachusetts, 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
St. Luke's Hospital
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States
Creighton University School of Medicine
Omaha, Nebraska, United States
Englewood Hospital Oncology Program
Englewood, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, 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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
Trinity Hospital
Minot, North Dakota, 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
Ireland Cancer Center
Cleveland, Ohio, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburg Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Potti A, Mukherjee S, Petersen R, Dressman HK, Bild A, Koontz J, Kratzke R, Watson MA, Kelley M, Ginsburg GS, West M, Harpole DH Jr, Nevins JR. A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer. N Engl J Med. 2006 Aug 10;355(6):570-80. doi: 10.1056/NEJMoa060467.
Fibla JJ, Cassivi SD, Brunelli A, Decker PA, Allen MS, Darling GE, Landreneau RJ, Putnam JB. Re-evaluation of the prognostic value of visceral pleura invasion in Stage IB non-small cell lung cancer using the prospective multicenter ACOSOG Z0030 trial data set. Lung Cancer. 2012 Dec;78(3):259-62. doi: 10.1016/j.lungcan.2012.09.010. Epub 2012 Oct 3.
Darling GE, Allen MS, Decker PA, Ballman K, Malthaner RA, Inculet RI, Jones DR, McKenna RJ, Landreneau RJ, Putnam JB Jr. Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective American College of Surgeons Oncology Group Z0030 trial. Chest. 2011 May;139(5):1124-1129. doi: 10.1378/chest.10-0859. Epub 2010 Sep 9.
Darling GE, Allen MS, Decker PA, Ballman K, Malthaner RA, Inculet RI, Jones DR, McKenna RJ, Landreneau RJ, Rusch VW, Putnam JB Jr. Randomized trial of mediastinal lymph node sampling versus complete lymphadenectomy during pulmonary resection in the patient with N0 or N1 (less than hilar) non-small cell carcinoma: results of the American College of Surgery Oncology Group Z0030 Trial. J Thorac Cardiovasc Surg. 2011 Mar;141(3):662-70. doi: 10.1016/j.jtcvs.2010.11.008.
Allen MS, Darling GE, Pechet TT, Mitchell JD, Herndon JE 2nd, Landreneau RJ, Inculet RI, Jones DR, Meyers BF, Harpole DH, Putnam JB Jr, Rusch VW; ACOSOG Z0030 Study Group. Morbidity and mortality of major pulmonary resections in patients with early-stage lung cancer: initial results of the randomized, prospective ACOSOG Z0030 trial. Ann Thorac Surg. 2006 Mar;81(3):1013-9; discussion 1019-20. doi: 10.1016/j.athoracsur.2005.06.066.
Other Identifiers
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CDR0000066988
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0030
Identifier Type: -
Identifier Source: org_study_id
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