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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000067072 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.
PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed. Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunohistochemistry staining method | Other |
| ||
| biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Lymph Nodes Examined Patients | Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Up to 5 years |
| Overall Survival in Bone Marrow Examined Patients | Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival in Lymph Nodes Examined Patients | Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Up to 5 years |
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Inclusion Criteria:
Patient must be ≥ 18 years old.
Patient must have ECOG/Zubrod status < 3.
Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
Patient must be medically fit for surgery.
Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
Patient must be available for follow-up.
If the patient is a survivor of a prior cancer, all of the following criteria must apply:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robbin G. Cohen, MD | University of Southern California | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Cancer Center | Mobile | Alabama | 36608 | United States | ||
| Mobile Infirmary Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21990404 | Result | Rusch VW, Hawes D, Decker PA, Martin SE, Abati A, Landreneau RJ, Patterson GA, Inculet RI, Jones DR, Malthaner RA, Cohen RG, Ballman K, Putnam JB Jr, Cote RJ. Occult metastases in lymph nodes predict survival in resectable non-small-cell lung cancer: report of the ACOSOG Z0040 trial. J Clin Oncol. 2011 Nov 10;29(32):4313-9. doi: 10.1200/JCO.2011.35.2500. Epub 2011 Oct 11. |
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Two-hundred and sixty-three participants were ultimately removed from the study for various reasons (e.g. initially ineligible, final histology other than non-small-cell lung cancer), leaving 1047 participants evaluable for study endpoints.
One thousand-three hundred and ten participants were enrolled between July 1999 and March 2004. Data was analyzed in June 2009 when all eligible participants could have been observed for at least 5 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery | All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| surgery | Procedure |
|
| Disease-Free Survival in Bone Marrow Examined Patients | Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Up to 5 years |
| Mobile |
| Alabama |
| 36640-0460 |
| United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033-0804 | United States |
| Huntington Cancer Center at Huntington Hospital | Pasadena | California | 91105 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| University of Colorado Health Sciences Center - Denver | Denver | Colorado | 80262 | United States |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Bayfront Medical Center | St. Petersburg | Florida | 33701 | 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 |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62701 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1062 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202-1886 | United States |
| McLaren Regional Cancer Center | Flint | Michigan | 48432 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| William Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Siteman Cancer Center | 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 |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Memorial Sloan-Kettering Cancer Center | 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 | 11794-8191 | United States |
| University Hospital at State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | 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 |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Westmoreland Regional Hospital | Greensburg | Pennsylvania | 15601-2282 | United States |
| Jameson Memorial Hospital | New Castle | Pennsylvania | 16105 | United States |
| Abramson Cancer Center of the 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 |
| 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 |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville | Tennessee | 37212 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6838 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Cancer Center at the University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Veterans Affairs Medical Center - Seattle | Seattle | Washington | 98108 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| University Cancer Center at University of Washington Medical Center | 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 |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery | All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Gender | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Operation performed (pulmonary resection) | Count of Participants | Participants |
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| Additional components of resection | Count of Participants | Participants |
| |||||||||||||||||||||||
| Extent of resection | Count of Participants | Participants |
| |||||||||||||||||||||||
| Tumor histology | Count of Participants | Participants |
| |||||||||||||||||||||||
| Pathologic T Stage | Staging was defined by tumor location and size. T1: w/o bronchoscopic evidence of invasion more proximal than the lobar bronchus. T2: invades the visceral pleura; associated with atelectasis/obstructive pneumonitis that extends to the hilar region but does not involve the entire lung. T3: chest wall, diaphragm, mediastinal pleura, parietal pericardium; tumor in the main bronchus <2cm distal to the carina (ca) but w/o involvement of the ca; T4: mediastinum, heart, great vessels, trachea, esophagus, vertebral body, ca, separate tumor nodule in the same lobe or tumor w malignant pleural effusion. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Pathologic N Stage | Nodal Involvement (N) was defined as: NX=Regional lymph nodes (LN) cannot be assessed, N0=No regional LN metastasis, N1=Metastasis to ipsilateral peribronchial and/or ipsilateral hilar LN and intrapulmonary nodes involved by direct extension of the primary tumor, N2= Metastasis to ipsilateral mediastinal and/or subcarinal LN, N3=Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or contralateral scalene, or supraclavicular LN. | Count of Participants | Participants |
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| Overall Pathologic Stage | Stage grouping was defined by T stage, N stage and M Stage. M stage: M0=Distant metastasis (DM) cannot be assessed, M0=No DM, M1=DM present. Overall Stage: IA=T1N0M0; IB=T2N0M0, IIA=T1N1M0, IIB=T2N1M0, T3N0M0; IIIA=T1N2M0, T2N2M0, T3N1M0, T3N2M0; IIIB=Any T, N3M0 or T4, Any N and M0; IV=Any T, Any N and M1 | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival in Lymph Nodes Examined Patients | Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Eligible participants with N0 non-small-cell lung cancer who had underwent pulmonary resection and were examined for OM | Posted | Median | 95% Confidence Interval | years | Up to 5 years |
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| Primary | Overall Survival in Bone Marrow Examined Patients | Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM | Posted | Median | 95% Confidence Interval | years | Up to 5 years |
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| Secondary | Disease-Free Survival in Lymph Nodes Examined Patients | Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Eligible participants with N0 non-small-cell lung cancer who had underwent pulmonary resection and were examined for OM | Posted | Median | 95% Confidence Interval | years | Up to 5 years |
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| Secondary | Disease-Free Survival in Bone Marrow Examined Patients | Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC). | Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM | Posted | Median | 95% Confidence Interval | years | Up to 5 years |
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No adverse events are collected on this trial. Adverse event would have only been collected for participant enrolled on both Z0030 and Z0040. Their adverse events are reported under Z0030 trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery | All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Rusch, MD | Memorial Sloan Kettering Cancer Center | 212-639-5873 | ruschv@mskcc.org |
| 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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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
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| Black/African American |
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| Asian |
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| American Indian/Alaska Native |
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| Other |
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| Segmentectomy |
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| Lobectomy |
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| Bilobectomy |
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| Pneumonectomy |
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| Vascular sleeve resection/arterioplasty |
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| Intrapericardial resection |
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| R2 |
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| Large cell |
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| Adenosquamous |
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| Non-small-cell lung cancer, other subtype or other |
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| T2=Tumor > 3 cm, main bronchus, >=2cm distal to ca |
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| T3=Tumor of any size directly invades certain area |
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| T4=Tumor of any size that invades certain area |
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| TX=Primary tumor cannot be assessed |
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| N2 |
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| NX |
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| IIA |
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| IIB |
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| IIIA |
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| IIIB |
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