Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma
2 other identifiers
interventional
1,310
2 countries
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lung-cancer
Started Jul 1999
Longer than P75 for phase_3 lung-cancer
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
February 16, 2017
CompletedFebruary 16, 2017
December 1, 2016
12.3 years
November 1, 1999
December 22, 2016
December 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Disease-Free Survival in Lymph Nodes Examined Patients
Up to 5 years
Disease-Free Survival in Bone Marrow Examined Patients
Up to 5 years
Study Arms (1)
Surgery
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Patient has undergone potentially curative therapy for all prior malignancies,
- 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),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
You may not qualify if:
- Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
- Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
- Patient has received prior chemotherapy or radiotherapy for this cancer.
- Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
- Patient for whom the surgeon plans to perform only a wedge resection for treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Providence Cancer Center
Mobile, Alabama, 36608, United States
Mobile Infirmary Medical Center
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
Related Publications (1)
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.
PMID: 21990404RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Valerie Rusch, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- STUDY CHAIR
Robbin G. Cohen, MD
University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
July 1, 1999
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 16, 2017
Results First Posted
February 16, 2017
Record last verified: 2016-12