Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overNCI, OtherCDR0000555324
CALGB-140503, ECOG-40503, NCT00499330

Trial Description

Summary

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

  • Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy).

Secondary

  • Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
  • Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection.
  • Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively.
  • Explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT scan and positron emission tomography (PET) imaging, and outcomes.
  • Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
  • Assess the utility of annual follow-up CT scan after surgical resection in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to tumor size (< 1 cm vs 1-1.5 cm vs > 1.5-2.0 cm) (based on the maximum dimension determined from the preoperative scan), histology (squamous cell carcinoma vs adenocarcinoma vs other), and smoking status (never smoked [smoked < 100 cigarettes over lifetime] vs former smoker [smoked > 100 cigarettes AND quit ≥ 1 year ago] vs current smoker [quit < 1 year ago or currently smokes]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo lobectomy by open thoracotomy or video-assisted thoracoscopic surgery (VATS).
  • Arm II: Patients undergo a wedge resection or anatomical segmentectomy by open thoracotomy or VATS.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria:
  • Preoperative criteria
  • Peripheral lung nodule ≤ 2 cm by CT scan
  • Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan
  • Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy)
  • No pure ground opacities or pathologically confirmed N1 or N2 disease
  • Intraoperative criteria
  • Histologically confirmed NSCLC
  • Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side*
  • Levels 4 and 7 nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration* NOTE: *Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately before or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
  • No evidence of locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No other malignancy within the past 3 years except for nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for this malignancy

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

  • National Cancer Institute
  • Radiation Therapy Oncology Group
  • American College of Surgeons
  • Southwest Oncology Group
Nasser K. Altorki, Study Chair
Harvey I. Pass, Study Chair
Daniel L. Miller, Study Chair
Kemp H. Kernstine, Study Chair

Trial Sites

U.S.A.

Alabama
Birmingham

UAB Comprehensive Cancer Center

Robert J. Cerfolio
Ph: 205-934-0309

Alaska
Anchorage

Alaska Breast Care and Surgery LLC

Keith S. Lanier
Ph: 503-215-6412

Alaska Women's Cancer Care

Keith S. Lanier
Ph: 503-215-6412

Anchorage Oncology Centre

Keith S. Lanier
Ph: 503-215-6412

Katmai Oncology Group

Keith S. Lanier
Ph: 503-215-6412

Providence Cancer Center

Keith S. Lanier
Ph: 503-215-6412

Arkansas
Little Rock

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Rangaswamy Govindarajan
Ph: 501-686-8274

California
Burbank

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Keith S. Lanier
Ph: 503-215-6412

Loma Linda

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Jason M Wallen
Ph: 800-741-8387

Long Beach

Veterans Affairs Medical Center - Long Beach

Amir Abolhoda
Ph: 562-826-8000

Pasadena

Huntington OutPatient Surgery Center

Robbin G. Cohen
Ph: 626-535-2420

Sacramento

University of California Davis Cancer Center

David T Cooke
Ph: 916-734-3089

Colorado
Colorado Springs

Memorial Hospital Cancer Center - Colorado Springs

Matthew G Blum
Ph: 719-365-2406

Denver

University of Colorado Cancer Center at UC Health Sciences Center

Nasser K. Altorki
Ph: 212-746-5156
Email: nkaltork@med.cornell.edu

Connecticut
Bridgeport

St. Vincent's Medical Center

Albert C DiMeo
Ph: 203-576-6329
Email: twhite@stvincents.org

Hartford

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

New Haven

Yale Cancer Center

Daniel J Boffa
Ph: 203-785-5702

Delaware
Lewes

Tunnell Cancer Center at Beebe Medical Center

Thomas L Bauer
Ph: 302-733-6227

Newark

Christiana Gynecologic Oncology, LLC

Thomas L Bauer
Ph: 302-733-6227

Delaware Clinical and Laboratory Physicians

Thomas L Bauer
Ph: 302-733-6227

Helen F. Graham Cancer Center at Christiana Hospital

Thomas L Bauer
Ph: 302-733-6227

Thomas L Bauer
Ph: 302-733-6227

Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center

Thomas L Bauer
Ph: 302-733-6227

Regional Hematology/Oncology, PA - Newark

Thomas L Bauer
Ph: 302-733-6227

Rehoboth Beach

Beebe Health Campus

Thomas L Bauer
Ph: 302-733-6227

Seaford

Nanticoke Memorial Hospital

Thomas L Bauer
Ph: 302-733-6227

Wilmington

Christiana Care Health System-Wilmington Hospital

Thomas L Bauer
Ph: 302-733-6227

Florida
Hollywood

Joe DiMaggio Children's Hospital

Mark I Block
Ph: 954-265-2234

Miami Beach

CCOP - Mount Sinai Medical Center

Michael Schwartz
Ph: 305-674-2625
Email: info@msccop.com

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Philip J. Stella
Ph: 734-712-4673

Illinois
Chicago

University of Chicago Cancer Research Center

Wicki T. Vigneswaran
Ph: 773-834-7424

Evanston

CCOP - Evanston

John A. Howington
Ph: 847-570-2109

Indiana
Indianapolis

Indiana University Melvin and Bren Simon Cancer Center

Thomas J Birdas
Ph: 317-274-2552

Veterans Affairs Medical Center - Indianapolis

Thomas J Birdas
Ph: 317-274-2552

William N. Wishard Memorial Hospital

Thomas J Birdas
Ph: 317-274-2552

Mishawaka

Memorial Regional Cancer Center Day Road

Thomas Joseph Reid
Ph: 800-284-7370

South Bend

Memorial Hospital of South Bend

Thomas Joseph Reid
Ph: 800-284-7370

Iowa
Clive

Medical Oncology and Hematology Associates-West Des Moines

Joseph D Verdirame
Ph: 402-398-6060

Mercy Cancer Center - West Lakes

Joseph D Verdirame
Ph: 402-398-6060

Council Bluffs

Alegent Health Mercy Hospital

Joseph D Verdirame
Ph: 402-398-6060

Des Moines

Medical Oncology and Hematology Associates at Mercy Cancer Center

Joseph D Verdirame
Ph: 402-398-6060

Mercy Cancer Center at Mercy Medical Center - Des Moines

Joseph D Verdirame
Ph: 402-398-6060

West Des Moines

Methodist West Hospital

Joseph D Verdirame
Ph: 402-398-6060

Kentucky
Bardstown

Flaget Memorial Hospital

Joseph D Verdirame
Ph: 402-398-6060

Corbin

Commonwealth Cancer Center-Corbin

Joseph D Verdirame
Ph: 402-398-6060

Lexington

Saint Joseph East

Joseph D Verdirame
Ph: 402-398-6060

United Radiation Oncology - Bob-O-Link Drive Office

Joseph D Verdirame
Ph: 402-398-6060

Louisville

Jewish Hospital

Joseph D Verdirame
Ph: 402-398-6060

Jewish Hospital Medical Center Northeast

Joseph D Verdirame
Ph: 402-398-6060

Saints Mary and Elizabeth Hospital

Joseph D Verdirame
Ph: 402-398-6060

Shepherdsville

Jewish Hospital Medical Center South

Joseph D Verdirame
Ph: 402-398-6060

Louisiana
New Orleans

Ochsner Cancer Institute at Ochsner Clinic Foundation

Brian L Pettiford
Ph: 504-842-3708

Maryland
Annapolis

DeCesaris Cancer Institute at Anne Arundel Medical Center

Stephen M Cattaneo
Ph: 443-481-1320
Email: kbodenhorn@aahs.org

Baltimore

Greater Baltimore Medical Center Cancer Center

Neri M. Cohen
Ph: 443-849-3706

Silver Spring

Holy Cross Hospital

Bryan M Steinberg
Ph: 301-270-2844

Massachusetts
Pittsfield

Berkshire Hematology Oncology, PC

Harvey Zimbler
Ph: 413-496-8205
Email: ggero@bhs1.org

Springfield

Baystate Medical Center

Seth A Kaufman
Ph: 413-794-9338

Michigan
Ann Arbor

Saint Joseph Mercy Cancer Center

Philip J. Stella
Ph: 734-712-4673

Dearborn

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Philip J. Stella
Ph: 734-712-4673

Flint

Genesys Hurley Cancer Institute

Philip J. Stella
Ph: 734-712-4673

Hurley Medical Center

Philip J. Stella
Ph: 734-712-4673

Jackson

Gayle M. Jacob Cancer Center at Allegiance Health

Philip J. Stella
Ph: 734-712-4673

Lansing

Sparrow Regional Cancer Center

Philip J. Stella
Ph: 734-712-4673

Livonia

St. Mary Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Pontiac

St. Joseph Mercy Oakland

Philip J. Stella
Ph: 734-712-4673

Port Huron

Mercy Regional Cancer Center at Mercy Hospital

Philip J. Stella
Ph: 734-712-4673

Saginaw

Seton Cancer Institute at Saint Mary's - Saginaw

Philip J. Stella
Ph: 734-712-4673

Warren

St. John Macomb Hospital

Philip J. Stella
Ph: 734-712-4673

Minnesota
Rochester

Mayo Clinic Cancer Center

Dennis A Wigle
Ph: 507-538-7623

Montana
Great Falls

Big Sky Oncology

Grant William Harrer
Ph: 406-731-8217

Nebraska
Grand Island

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

Joseph D Verdirame
Ph: 402-398-6060

Kearney

Good Samaritan Cancer Center at Good Samaritan Hospital

Joseph D Verdirame
Ph: 402-398-6060

Heartland Hematology and Oncology

Joseph D Verdirame
Ph: 402-398-6060

Lincoln

Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

Joseph D Verdirame
Ph: 402-398-6060

Omaha

Alegant Health Cancer Center at Bergan Mercy Medical Center

Joseph D Verdirame
Ph: 402-398-6060

Creighton University Medical Center

Joseph D Verdirame
Ph: 402-398-6060

Hematology/Oncology Consultants

Joseph D Verdirame
Ph: 402-398-6060

Immanuel Medical Center

Joseph D Verdirame
Ph: 402-398-6060

Lakeside Hospital

Joseph D Verdirame
Ph: 402-398-6060

Papillion

Midlands Cancer Center at Midlands Community Hospital

Joseph D Verdirame
Ph: 402-398-6060

New Jersey
Basking Ridge

Memorial Sloan-Kettering Cancer Center - Basking Ridge

James Huang
Ph: 212-639-7202

Brick

Ocean Medical Center at Meridian Health

Thomas L Bauer
Ph: 732-776-4240

Manahawkin

Southern Ocean County Radiation Oncology, LLC

Thomas L Bauer
Ph: 732-776-4240

Neptune

Jersey Shore Cancer Center at Jersey Shore University Medical Center

Thomas L Bauer
Ph: 732-776-4240

Red Bank

Booker Cancer Center at Riverview Medical Center

Thomas L Bauer
Ph: 732-776-4240

New York
Buffalo

Roswell Park Cancer Institute

Chukwumere E. Nwogu
Ph: 877-275-7724

Commack

Memorial Sloan-Kettering Cancer Center

James Huang
Ph: 212-639-7202

New York

Memorial Sloan-Kettering Cancer Center

James Huang
Ph: 212-639-7202

Rochester

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jonathan W Friedberg
Ph: 585-275-5830

Rockville Centre

Memorial Sloan-Kettering Cancer Center - Rockville Centre

James Huang
Ph: 212-639-7202

Syracuse

SUNY Upstate Medical University Hospital

Leslie J. Kohman
Ph: 315-464-5476

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

James Huang
Ph: 212-639-7202

North Carolina
Asheville

Veterans Affairs Medical Center - Asheville

John C. Lucke
Ph: 828-299-5909

Clinton

Southeastern Medical Oncology Center-Clinton

James N. Atkins
Ph: 919-580-0000

Durham

Duke Cancer Institute

Jeffrey Crawford
Ph: 888-275-3853

Goldsboro

Southeastern Medical Oncology Center - Goldsboro

James N. Atkins
Ph: 919-580-0000

Wayne Memorial Hospital, Incorporated

James N. Atkins
Ph: 919-580-0000

Ohio
Canton

Mercy Cancer Center at Mercy Medical Center

Mitchell Haut
Ph: 888-293-4673

Cincinnati

Bethesda North Hospital

Joseph D Verdirame
Ph: 402-398-6060

Good Samaritan Hospital Cancer Treatment Center

Joseph D Verdirame
Ph: 402-398-6060

TriHealth Cancer Institute-Anderson

Joseph D Verdirame
Ph: 402-398-6060

TriHealth Cancer Institute-Westside

Joseph D Verdirame
Ph: 402-398-6060

Cleveland

Case Comprehensive Cancer Center

Philip A Linden
Ph: 800-641-2422

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Nasser K. Altorki
Ph: 212-746-5156
Email: nkaltork@med.cornell.edu

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Subrato J Deb
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Oregon
Clackamas

Clackamas Radiation Oncology Center

Keith S. Lanier
Ph: 503-215-6412

Providence Oncology and Hematology Care Southeast

Keith S. Lanier
Ph: 503-215-6412

Newberg

Providence Newberg Medical Center

Keith S. Lanier
Ph: 503-215-6412

Oregon City

Willamette Falls Hospital

Keith S. Lanier
Ph: 503-215-6412

Portland

Providence Cancer Center at Providence Portland Medical Center

Keith S. Lanier
Ph: 503-215-6412

Providence St. Vincent Medical Center

Keith S. Lanier
Ph: 503-215-6412

Pennsylvania
Danville

Geisinger Cancer Institute at Geisinger Health

Matthew A Facktor
Ph: 570-271-5251

Monroeville

Forbes Regional Hospital

Rodney J. Landreneau
Ph: 877-284-2000

Philadelphia

Fox Chase Cancer Center - Philadelphia

Walter J. Scott
Ph: 215-728-4790

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Nathaniel R Evans
Ph: 215-955-6084

Pittsburgh

Allegheny Cancer Center at Allegheny General Hospital

Rodney J. Landreneau
Ph: 877-284-2000

UPMC Cancer Centers

Matthew J Schuchert
Ph: 412-647-2811

Reading

St. Joseph Medical Center

Susan M Trocciola
Ph: 610-378-2336
Email: danielward2@catholichealth.net

Sayre

Guthrie Cancer Center at Guthrie Clinic Sayre

Bradley W Lash
Ph: 800-836-0388

Tennessee
Chattanooga

H. Clay Evans Johnson Cancer Center at Memorial Hospital

Joseph D Verdirame
Ph: 402-398-6060

Hixson

Pulmonary Medicine Center of Chattanooga-Hixson

Joseph D Verdirame
Ph: 402-398-6060

Knoxville

U.T. Medical Center Cancer Institute

Thomas E. Gaines
Ph: 865-305-9773

Nashville

Vanderbilt-Ingram Cancer Center

Eric L Grogan
Ph: 800-811-8480

Ooltewah

Memorial GYN Plus

Joseph D Verdirame
Ph: 402-398-6060

Utah
American Fork

American Fork Hospital

David R Goff
Ph: 801-387-7426

Vermont
Burlington

University of Vermont Cancer Center

Bruce Leavitt
Ph: 802-656-4101

Virginia
Charlottesville

University of Virginia Cancer Center

Benjamin D Kozower
Ph: 434-243-6143

Hampton

Sentara Cancer Institute at Sentara CarePlex Hospital

Peter M Moy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Norfolk

Sentara Cancer Institute at Sentara Norfolk General Hospital

Peter M Moy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Richmond

Virginia Commonwealth University Massey Cancer Center

Anthony D Cassano
Ph: 804-628-1939

Williamsburg

Sentara Williamsburg Community Hospital

Peter M Moy
Ph: 888-823-5923
Email: ctsucontact@westat.com

Washington
Bremerton

Harrison Medical Center

Joseph D Verdirame
Ph: 402-398-6060

Olympic Hematology and Oncology

Joseph D Verdirame
Ph: 402-398-6060

Burien

Highline Medical Center Cancer Center

Joseph D Verdirame
Ph: 402-398-6060

Enumclaw

Saint Elizabeth Hospital

Joseph D Verdirame
Ph: 402-398-6060

Federal Way

St. Francis Hospital

Joseph D Verdirame
Ph: 402-398-6060

Lakewood

St. Clare Hospital

Joseph D Verdirame
Ph: 402-398-6060

Longview

Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center

Keith S. Lanier
Ph: 503-215-6412

Poulsbo

Harrison Poulsbo Hematology and Onocology

Joseph D Verdirame
Ph: 402-398-6060

Tacoma

Franciscan Research Center-Northwest Medical Plaza

Joseph D Verdirame
Ph: 402-398-6060

Northwest Medical Specialties, PLLC - Tacoma

Joseph D Verdirame
Ph: 402-398-6060

Vancouver

Southwest Washington Medical Center Cancer Center

Keith S. Lanier
Ph: 503-215-6412

Canada

British Columbia
Surrey

Surrey Memorial Hospital

Ahmad S Ashrafi
Ph: 888-823-5923
Email: ctsucontact@westat.com

Ontario
Hamilton

St. Joseph's Hospital - Charlton Campus

Yaron Shargall
Ph: 905-522-1155ext36115
Email: research@stjoes.ca

London

London Regional Cancer Program at London Health Sciences Centre

Richard A Malthaner
Ph: 519-685-8600

Ottawa

Ottawa Hospital Regional Cancer Centre - General Campus

Andrew J Seely
Ph: 613-761-4395

Toronto

Princess Margaret Hospital

Marc de Perrot
Ph: 416-946-4501
Email: clinical.trials@uhn.on.ca

Quebec
Montreal

Hopital Notre-Dame du CHUM

Moishe Liberman
Ph: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca

Quebec

Fondation de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Paula A Ugalde Figueroa
Ph: 418-656-8711

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00499330
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.