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Lung CancerPhase 2NCT00003692

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

A Phase 2 study testing therapeutic thoracoscopy and video-assisted surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 115 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
therapeutic thoracoscopy and video-assisted surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
115 sitesin 3 countries
Study dates
Dec 1998to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

115 sites in 3 countries.

115 sites in 3 countries

United States112 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Veterans Affairs Medical Center - Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Veterans Affairs Medical Center - Gainsville

    Gainesville, Florida, 32608-1197

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Veterans Affairs Medical Center - Nashville

    Nashville, Tennessee, 37212

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • Veterans Affairs Medical Center - Omaha

    Omaha, Nebraska, 68105

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • Veterans Affairs Medical Center - Togus

    Togus, Maine, 04330

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Sooner State

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Lombardi Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Puerto Rico2 sites

  • MBCCOP - San Juan

    San Juan, 00927-5800

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

South Africa1 site

  • Pretoria Academic Hospitals

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Conditions
Lung Cancer
Being tested
therapeutic thoracoscopy, video-assisted surgery
Keywords
occult non-small cell lung cancer, stage I non-small cell lung cancer, stage 0 non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic thoracoscopyProcedure or surgery

  • video-assisted surgeryProcedure or surgery

Study groups in NCT00003692
Study groupRoleWhat they receive
video-assisted surgeryExperimentalPatients 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.
Receives: Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survival

    Measured: up to 5 years

  2. failure-free survival

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2004 (estimated)
  2. Study startDec 1998
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003692
Sponsor's protocol ID
CALGB-39802
Other IDs
U10CA031946, CLB-39802, E-C39802, CDR0000066795
Status last verified
Aug 2023
First submitted
1 Nov 1999
Last updated
18 Aug 2023
Results posted
No
Data monitoring committee
No

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.

    PubMed 17971599

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing therapeutic thoracoscopy and video-assisted surgery in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 115 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Puerto Rico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003692, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.

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