Lymph Node Removal in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer - Full Text View

Sponsor:	American College of Surgeons
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003831

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Procedure: conventional surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	1000
Study Start Date:	July 1999

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.

OUTLINE: This is a randomized study.

Patients undergo lymph node sampling from multiple sites inside the chest. Patients with negative lymph nodes are randomized to 1 of 2 treatment arms.

Arm I (Mediastinal Lymph Node Sampling): No more lymph nodes are removed. Patients undergo pulmonary resection.
Arm II (Mediastinal 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.

PROJECTED ACCRUAL: A total of 1,000 patients (500 per arm) will be accrued for this study over 5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy proven or suspected, clinically resectable stage I or II (T1 or T2, N0 or non-hilar N1, M0) non-small cell carcinoma of the lung (NSCLC)
- Squamous cell carcinoma, adenocarcinoma, or large cell carcinoma
If tissue diagnosis not established preoperatively, must be established intraoperatively prior to registration/randomization
If preoperative mediastinoscopy has been performed, hilar lymph nodes must be certified to be less than 1 cm in the short axis diameter by preoperative CT scan, and no N2 disease found at mediastinoscopy
If preoperative mediastinoscopy has not been performed, all lymph nodes in the hilum and mediastinum must measure less than 1 cm in the short axis diameter on preoperative CT scan
Candidate for complete resection via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection
- Planned wedge resection only not eligible
All sampled nodes must be negative by frozen section assessment

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2 OR
Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Medically fit for surgery
No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, and deemed to be at low risk for recurrence from prior curatively treated malignancies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for NSCLC

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy for NSCLC

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003831

Hide Study Locations

Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
United States, California
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
Stanford University Medical Center
Stanford, California, United States, 94305-5408
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0128
United States, Florida
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Shands Cancer Center at the University of Florida
Gainesville, Florida, United States, 32610-0342
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States, 32608-1197
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
St. John's Hospital
Springfield, Illinois, United States, 62701
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
Jewish Hospital
Louisville, Kentucky, United States, 40202-1886
United States, Louisiana
Medical Center of Southwest Louisiana
Lafayette, Louisiana, United States, 70506
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2620
Rhode Island Hospital
Boston, Massachusetts, United States, 02114-2620
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Luke's Hospital
Duluth, Minnesota, United States, 55805-2193
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
United States, Nebraska
Creighton University School of Medicine
Omaha, Nebraska, United States, 68131
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States, 68105
United States, New Jersey
Englewood Hospital Oncology Program
Englewood, New Jersey, United States, 07631
Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11790-8191
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Dakota
Trinity Hospital
Minot, North Dakota, United States, 58701
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0558
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Jameson Memorial Hospital
New Castle, Pennsylvania, United States, 16105
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, United States, 15213
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, United States, 15243-1899
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
University of Pittsburg Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15213-2582
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States, 15601-2282
United States, Tennessee
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195-6310
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98195-6310
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-7375
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark S. Allen, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Allen MS, Darling GE, Decker PA, et al.: Number of lymph nodes harvested from a mediastinal lymphadenectomy: results of the randomized, prospective ACOSOG Z0030 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7555, 398s, 2007.

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.

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. Erratum in: N Engl J Med. 2007 Jan 11;356(2):201-2.

Study ID Numbers:	CDR0000066988, ACOSOG-Z0030
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003831 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009