Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003692
First received: November 1, 1999
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Procedure: therapeutic thoracoscopy
Procedure: video-assisted surgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 128
Study Start Date: December 1998
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.

OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Suspected or histologically documented non-small cell lung cancer Solitary, peripheral lung lesion that is no greater than 3.0 cm No metastatic disease No positive lymph nodes at mediastinoscopy At least 5 years since diagnosis of non-small cell or small cell lung cancer

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: FEV1 at least 1.0 L or at least 50% of predicted Other: No significant comorbid medical or psychiatric condition No other active malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003692

  Hide Study Locations
Locations
United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Cancer Center, Georgetown University
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, United States, 32608-1197
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Veterans Affairs Medical Center - Togus
Togus, Maine, United States, 04330
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States, 68105
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Veterans Affairs Medical Center - Albany
Albany, New York, United States, 12208
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Veterans Affairs Medical Center - New York
New York, New York, United States, 10010
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
University of Rochester Cancer Center
Rochester, New York, United States, 14642
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
CCOP - Sooner State
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, United States, 37212
United States, Vermont
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States, 23249
United States, Wisconsin
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00927-5800
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
South Africa
Pretoria Academic Hospitals
Pretoria, South Africa, 0001
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Eastern Cooperative Oncology Group
Investigators
Study Chair: Scott J. Swanson, MD Dana-Farber/Brigham and Women's Cancer Center
Study Chair: John R. Roberts, MD, MBA Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Publications:
Swanson SJ, Herndon J, D'Amico A, et al.: Results of CALGB 39802: feasibility of video-assisted thoracic surgery (VATS) lobectomy for early stage lung cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1158, 2002.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003692     History of Changes
Other Study ID Numbers: CDR0000066795, U10CA031946, CLB-39802, E-C39802
Study First Received: November 1, 1999
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
occult non-small cell lung cancer
stage I non-small cell lung cancer
stage 0 non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014