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

December 22, 2016 updated by: Alliance for Clinical Trials in Oncology

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36640-0460
        • Mobile Infirmary Medical Center
      • Mobile, Alabama, United States, 36608
        • Providence Cancer Center
    • California
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pasadena, California, United States, 91105
        • Huntington Cancer Center at Huntington Hospital
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center - Denver
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Saint Petersburg, Florida, United States, 33701
        • Bayfront Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62701
        • Cancer Institute at St. John's Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242-1062
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1886
        • Jewish Hospital
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48432
        • McLaren Regional Cancer Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University School of Medicine
      • Omaha, Nebraska, United States, 68105
        • Veterans Affairs Medical Center - Omaha
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794-8191
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, United States, 13210
        • University Hospital at State University of New York - Upstate Medical University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0558
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97239
        • Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601-2282
        • Westmoreland Regional Hospital
      • New Castle, Pennsylvania, United States, 16105
        • Jameson Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States, 15212-4772
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15243-1899
        • St. Clair Memorial Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Hospital
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, United States, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, United States, 98195-6310
        • University Cancer Center at University of Washington Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9300
        • West Virginia University Hospitals
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-7375
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient must be ≥ 18 years old.
  2. Patient must have ECOG/Zubrod status < 3.
  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.
  4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
  5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
  6. 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.
  7. Patient must be medically fit for surgery.
  8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
  9. 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.
  10. Patient must be available for follow-up.

  11. 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:

  1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
  2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
  3. Patient has received prior chemotherapy or radiotherapy for this cancer.
  4. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
  5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: surgery
Procedure: biopsy
Other: immunohistochemistry staining method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival in Lymph Nodes Examined Patients
Time Frame: 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).
Up to 5 years
Overall Survival in Bone Marrow Examined Patients
Time Frame: 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).
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival in Lymph Nodes Examined Patients
Time Frame: 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).
Up to 5 years
Disease-Free Survival in Bone Marrow Examined Patients
Time Frame: 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).
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Robbin G. Cohen, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOSOG-Z0040
  • CDR0000067072 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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