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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000066988 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymph node sampling | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Up to 5 years |
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Inclusion Criteria:
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:
Intra-operative:
Exclusion Criteria:
A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S. Allen, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36640-0460 | United States | ||
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16899777 | Background | 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. |
|
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| Los Angeles |
| California |
| 90048 |
| United States |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange | California | 92868 | United States |
| Huntington Cancer Center at Huntington Hospital | Pasadena | California | 91105 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94143-0128 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5408 | United States |
| Veterans Affairs Medical Center - Gainesville | Gainesville | Florida | 32608-1197 | United States |
| Shands Cancer Center at the University of Florida | Gainesville | Florida | 32610-0342 | United States |
| Holmes Regional Medical Center | Melbourne | Florida | 32901 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Edward Hospital Cancer Center | Naperville | Illinois | 60540 | United States |
| St. John's Hospital | Springfield | Illinois | 62701 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202-1886 | United States |
| Medical Center of Southwest Louisiana | Lafayette | Louisiana | 70506 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114-2620 | United States |
| Rhode Island Hospital | Boston | Massachusetts | 02114-2620 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| William Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
| St. Luke's Hospital | Duluth | Minnesota | 55805-2193 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Veterans Affairs Medical Center - Omaha | Omaha | Nebraska | 68105 | United States |
| Creighton University School of Medicine | Omaha | Nebraska | 68131 | United States |
| Englewood Hospital Oncology Program | Englewood | New Jersey | 07631 | United States |
| Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Long Island Cancer Center at Stony Brook University Hospital | Stony Brook | New York | 11790-8191 | United States |
| Trinity Hospital | Minot | North Dakota | 58701 | United States |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | 45220-2288 | United States |
| Tri-Health Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267-0558 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| Westmoreland Regional Hospital | Greensburg | Pennsylvania | 15601-2282 | United States |
| Jameson Memorial Hospital | New Castle | Pennsylvania | 16105 | United States |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| University of Pittsburg Medical Center - Shadyside Hospital | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| Presbyterian-University Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC St. Margaret | Pittsburgh | Pennsylvania | 15215 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| St. Clair Memorial Hospital | Pittsburgh | Pennsylvania | 15243-1899 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Saint Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98104 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-6310 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98195-6310 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506-9300 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-7375 | United States |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3002 | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| 23040416 | Result | 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. |
| 20829340 | Result | 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. |
| 21335122 | Result | 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. |
| 16488712 | Result | 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. |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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