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

Video-Assisted Lobectomy for Peripheral (no Greater Than 3 cm), N0, Non-Small Cell Lung Cancer: A Phase II Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: video-assisted surgery; 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.

Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
failure-free survival	up to 5 years
survival	up to 5 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); 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

Publications and helpful links

General Publications

• Swanson SJ, Herndon JE 2nd, D'Amico TA, Demmy TL, McKenna RJ Jr, Green MR, Sugarbaker DJ. Video-assisted thoracic surgery lobectomy: report of CALGB 39802--a prospective, multi-institution feasibility study. J Clin Oncol. 2007 Nov 1;25(31):4993-7. doi: 10.1200/JCO.2007.12.6649.
• 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.

Study record dates

Study Major Dates

• Study Start: December 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: April 8, 2004
• First Posted (Estimated): April 9, 2004

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer; occult non-small cell lung cancer; stage 0 non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CALGB-39802; U10CA031946 (U.S. NIH Grant/Contract); CLB-39802; E-C39802; CDR0000066795 (Registry Identifier: NCI Physicians Data Query)