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Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer Clinical research trials and Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer. Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer  Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
For Condition: adenocarcinoma of the lung,stage 2 non-small cell lung cancer,large cell lung cancer,squamous cell lung cancer,stage 1 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkAllen, Study Chair, Mayo Clinic Cancer Center
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Jameson Memorial Hospital
New Castle, Pennsylvania, 16105
United States
Jewish Hospital
Louisville, Kentucky, 40202-1886
United States
Trinity Hospital
Minot, North Dakota, 58701
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-7375
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Huntington Cancer Center at Huntington Hospital
Pasadena, California, 91105
United States
Valley Hospital
Ridgewood, New Jersey, 07450
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0558
United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
Shands Cancer Center at the University of Florida
Gainesville, Florida, 32610-0342
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Englewood Hospital Oncology Program
Englewood, New Jersey, 07631
United States
St. Clair Memorial Hospital
Pittsburgh, Pennsylvania, 15243-1899
United States
St. Vincent's Hospital
Fitzroy, Victoria, 3065
Australia
Rhode Island Hospital
Boston, Massachusetts, 02114-2620
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114-2620
United States
Holmes Regional Medical Center
Melbourne, Florida, 32901
United States
St. John's Hospital
Springfield, Illinois, 62701
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
United States
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Australia
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
University of Pittsburg Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, 15213-2582
United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601-2282
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Edward Hospital Cancer Center
Naperville, Illinois, 60540
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Presbyterian-University Hospital
Pittsburgh, Pennsylvania, 15213
United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36640-0460
United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104
United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98195-6310
United States
University of Washington Medical Center
Seattle, Washington, 98195-6310
United States
Saint Thomas Hospital
Nashville, Tennessee, 37205
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, 32608-1197
United States
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, 68105
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Central Baptist Hospital
Lexington, Kentucky, 40503
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
Creighton University School of Medicine
Omaha, Nebraska, 68131
United States
Medical Center of Southwest Louisiana
Lafayette, Louisiana, 70506
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11790-8191
United States
Medical Center of Central Georgia
Macon, Georgia, 31201
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Jackson Memorial Hospital
Miami, Florida, 33136
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
United States
St. Luke's Hospital
Duluth, Minnesota, 55805-2193
United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326
United States
Additional Information:
Study ID Numbers: CDR0000066988; ACOSOG-Z0030
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003831
Other Adenocarcinoma Of The Lung Studies:
1. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
2. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
3. Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
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