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

Phase 3

Completed

Conditions: Lung Cancer

Interventions: Other: immunohistochemistry staining method
Procedure: biopsy
Procedure: surgery

Registration Number: NCT00003901

Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

Detailed Description: OBJECTIVES:

* Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.

* Determine the relationship between these indicators and conventional histology.

* Model survival considering the indicators and other patient attributes that are of prime prognostic significance.

* Determine the relationships between the indicators and the site of first recurrence in these patients.

* Determine the prevalence of the indicators in these patients.

* Determine the relationships between the indicators and disease free survival in these patients.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1310

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:
1. Patient has undergone potentially curative therapy for all prior malignancies,
2. 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),
3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	immunohistochemistry staining method	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.
Surgery	biopsy	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.
Surgery	surgery	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival in Lymph Nodes Examined Patients	Up to 5 years	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).
Overall Survival in Bone Marrow Examined Patients	Up to 5 years	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).

Secondary Outcome Measures

Name	Time	Method
Disease-Free Survival in Lymph Nodes Examined Patients	Up to 5 years	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).
Disease-Free Survival in Bone Marrow Examined Patients	Up to 5 years	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).

Trial Locations

Locations (58): Long Island Cancer Center at Stony Brook University Hospital
🇺🇸
Stony Brook, New York, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Providence Cancer Center
🇺🇸
Mobile, Alabama, United States
Huntington Cancer Center at Huntington Hospital
🇺🇸
Pasadena, California, United States
Bayfront Medical Center
🇺🇸
Saint Petersburg, Florida, United States
University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
Cancer Institute at St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸
Springfield, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸
Iowa City, Iowa, United States
McLaren Regional Cancer Center
🇺🇸
Flint, Michigan, United States
William Beaumont Hospital - Royal Oak
🇺🇸
Royal Oak, Michigan, United States
Hurley Medical Center
🇺🇸
Flint, Michigan, United States
Siteman Cancer Center
🇺🇸
Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
🇺🇸
Syracuse, New York, United States
Ireland Cancer Center
🇺🇸
Cleveland, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
Jameson Memorial Hospital
🇺🇸
New Castle, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸
Wynnewood, Pennsylvania, United States
Western Pennsylvania Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
St. Clair Memorial Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Cottonwood Hospital Medical Center
🇺🇸
Murray, Utah, United States
Veterans Affairs Medical Center - Seattle
🇺🇸
Seattle, Washington, United States
West Virginia University Hospitals
🇺🇸
Morgantown, West Virginia, United States
University Cancer Center at University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸
Madison, Wisconsin, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦
London, Ontario, Canada
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Charles M. Barrett Cancer Center at University Hospital
🇺🇸
Cincinnati, Ohio, United States
UCSF Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Saint Thomas Hospital
🇺🇸
Nashville, Tennessee, United States
LDS Hospital
🇺🇸
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸
Nashville, Tennessee, United States
Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
University of Colorado Health Sciences Center - Denver
🇺🇸
Denver, Colorado, United States
Creighton University School of Medicine
🇺🇸
Omaha, Nebraska, United States
Veterans Affairs Medical Center - Omaha
🇺🇸
Omaha, Nebraska, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸
Portland, Oregon, United States
Cancer Institute at Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Medical College of Wisconsin Cancer Center
🇺🇸
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸
Milwaukee, Wisconsin, United States
Alexian Brothers Medical Center
🇺🇸
Elk Grove Village, Illinois, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Cancer Center at the University of Virginia
🇺🇸
Charlottesville, Virginia, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Westmoreland Regional Hospital
🇺🇸
Greensburg, Pennsylvania, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸
Philadelphia, Pennsylvania, United States
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
University of California Davis Cancer Center
🇺🇸
Sacramento, California, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States