Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

Pre-Resection Minimally Invasive Surgical Restaging of Stage III (Mediastinal Node Positive) Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.

PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.

OBJECTIVES:

Primary Objective:

1. Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.

Secondary Objectives:

  1. Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.
  2. Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico School of Medicine Medical Sciences Campus
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Northeast Alabama Regional Medical Center
    • California
      • La Jolla, California, United States, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital Comprehensive Cancer Center
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • West Palm Beach, Florida, United States, 33401
        • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
      • Rockford, Illinois, United States, 61108
        • Saint Anthony Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East - Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Medical Center - Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center - University Campus
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Medical Center - St. Joseph
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, United States, 89106
        • Veterans Affairs Medical Center - Las Vegas
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • New York
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • Veterans Affairs Medical Center - Asheville
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Concord, North Carolina, United States, 28025
        • NorthEast Oncology Associates
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Fayetteville, North Carolina, United States, 28302-2000
        • Cape Fear Valley Health System
      • Kinston, North Carolina, United States, 28503-1678
        • Lenoir Memorial Hospital Cancer Center
      • Pinehurst, North Carolina, United States, 28374
        • Firsthealth Moore Regional Hospital
      • Wilmington, North Carolina, United States, 28402-9025
        • New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Veterans Affairs Medical Center - Fargo
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Lifespan: The Miriam Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Veterans Affairs Medical Center - Dallas
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, United States, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Martha Jefferson Hospital
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Norfolk
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center
    • Wisconsin
      • Rhinelander, Wisconsin, United States, 54501
        • Ministry Medical Group - Northern Region

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

  1. Histologic Documentation: All patients must have histologic documentation of Stage IIIA non-small cell lung cancer on the basis of involved N2 nodes from a documented mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
  2. Prior Treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 Gy) or radiotherapy alone (greater than or equal to 40 Gy) must be completed within 60 days of registration.
  3. No distant metastatic disease or local disease progression. Patients with responding or stable local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
  4. No previous intrapleural surgery on the ipsilateral side.
  5. ECOG Performance Status: 0-2

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video-thorascopy + surgery
Patients will undergo ipsilateral video-thorascopic evaluation. Patients may undergo surgery at the discretion of the surgeon and treating physicians.
Procedure: videothoracoscopy

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: Michael Jaklitsch, MD, Dana-Farber/Brigham and Women's Cancer Center

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

  • Jaklitsch MT, Gu L, Harpole DH, et al.: Prospective phase II trial of pre-resection thoracoscopic (VATS) restaging following neoadjuvant therapy for IIIA(N2) non-small cell lung cancer (NSCLC): results of CALGB 39803. [Abstract] J Clin Oncol 23 (Suppl 16): A-7065, 636s, 2005.

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

September 1, 1998

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

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 (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-39803
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CLB-39803
  • CDR0000066632 (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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