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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

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. AltorkiStudy Chair

Harvey I. PassStudy Chair

Daniel L. MillerStudy Chair

Kemp H. KernstineStudy Chair

Trial Sites

U.S.A.
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Rangaswamy Govindarajan Ph: 501-686-8274
California
  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
 Ian L Gordon 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
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 John D. Mitchell Ph: 720-848-0650
  Colorado Springs
 Memorial Hospital Cancer Center - Colorado Springs
 Matthew G Blum Ph: 719-776-5275
  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
Georgia
  Decatur
 Veterans Affairs Medical Center - Atlanta (Decatur)
 Felix G Fernandez Ph: 404-321-6111ext7632
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-4673
Illinois
  Chicago
 Cancer and Leukemia Group B
 Nasser K. Altorki Ph: 212-746-5156
  Email: nkaltork@med.cornell.edu
 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
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Rodney J. Landreneau Ph: 888-562-4763
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
 Greenebaum Cancer Center at University of Maryland Medical Center
 Whitney M Burrows Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Bel Air
 Upper Chesapeake Medical Center
 Whitney M Burrows Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Towson
 Cancer Institute at St. Joseph Medical Center
 Ziv Gamliel Ph: 410-337-4569
  Email: patriciajohnson@catholichealth.net
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Daniel C Wiener Ph: 617-636-5000
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
  Pittsfield
 Berkshire Hematology Oncology, PC
 Harvey Zimbler Ph: 413-496-8205
  Email: ggero@bhs1.org
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
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 David W Johnstone Ph: 414-805-4380
  Email: cancerhelp@dartmouth.edu
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Thomas L Bauer Ph: 302-733-6227
New York
  Buffalo
 Roswell Park Cancer Institute
 Chukwumere E. Nwogu Ph: 877-275-7724
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Jonathan W Friedberg Ph: 585-275-5830
  Syracuse
 SUNY Upstate Medical University Hospital
 Leslie J. Kohman Ph: 315-464-5476
North Carolina
  Durham
 Duke Cancer Institute
 Jeffrey Crawford Ph: 888-275-3853
  Goldsboro
 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
  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
 Patrick Ross Ph: 866-627-7616
  Email: osu@emergingmed.com
 Nasser K. Altorki Ph: 212-746-5156
  Email: nkaltork@med.cornell.edu
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Subrato J Deb Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Alison K Conlin Ph: 503-215-6412
  Newberg
 Providence Newberg Medical Center
 Alison K Conlin Ph: 503-215-6412
  Oregon City
 Willamette Falls Hospital
 Alison K Conlin Ph: 503-215-6412
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 Alison K Conlin Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Alison K Conlin Ph: 503-215-6412
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Matthew A Facktor Ph: 570-271-5251
  New Castle
 Jameson Memorial Hospital - North Campus
 Matthew J Schuchert Ph: 412-647-2811
  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
 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
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 David L Grisell Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Grove Commons
 David L Grisell Ph: 864-241-6251
 Greenville Memorial Hospital
 David L Grisell Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 David L Grisell Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 David L Grisell Ph: 864-241-6251
Tennessee
  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
Utah
  American Fork
 American Fork Hospital
 David R Goff Ph: 801-387-7426
  Cedar City
 Sandra L. Maxwell Cancer Center
 David R Goff Ph: 801-387-7426
  Logan
 Logan Regional Hospital
 David R Goff Ph: 801-387-7426
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 David R Goff Ph: 801-387-7426
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 David R Goff Ph: 801-387-7426
  Provo
 Utah Valley Regional Medical Center - Provo
 David R Goff Ph: 801-387-7426
  Saint George
 Dixie Regional Medical Center - East Campus
 David R Goff Ph: 801-387-7426
  Salt Lake City
 LDS Hospital
 David R Goff Ph: 801-387-7426
 Utah Cancer Specialists at UCS Cancer Center
 David R Goff Ph: 801-387-7426
Vermont
  Burlington
 Vermont Cancer Center at University of Vermont
 Bruce Leavitt Ph: 802-656-8990
Virginia
  Charlottesville
 University of Virginia Cancer Center
 Benjamin D Kozower Ph: 434-243-6143
  Fredericksburg
 Mary Washington Regional Cancer Center
 John T Sherwood Ph: 540-741-1769
Washington
  Anacortes
 Cancer Care Center at Island Hogs
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Bellingham
 St. Joseph Cancer Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Bremerton
 Olympic Hematology and Oncology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Edmonds
 Swedish Cancer Institute at Stevens Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Issaquah
 Swedish Medical Center - Issaquah Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Kennewick
 Columbia Basin Hematology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Kirkland
 Cascade Cancer Center at Evergreen Hospital Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Mount Vernon
 Skagit Valley Hospital Cancer Care Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Poulsbo
 Harrison Poulsbo Hematology and Onocology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Seattle
 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Group Health Central Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Swedish Medical Center-Ballard Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 University Cancer Center at University of Washington Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Spokane
 Cancer Care Northwest - Spokane South
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Rockwood Clinic Cancer Treatment Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Vancouver
 Southwest Washington Medical Center Cancer Center
 Alison K Conlin Ph: 503-215-6412
  Wenatchee
 Confluence Health - Wenatchee Valley Medical Center
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
Canada
British Columbia
  Surrey
 Surrey Memorial Hospital
 Ahmad S Ashrafi Ph: 888-823-5923
  Email: ctsucontact@westat.com
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Madelaine M Plourde Ph: 902-473-6000
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
 Jean Deslauriers Ph: 418-656-8711
  Sherbrooke
 CHUS-Hopital Fleurimont
 Marco Sirois Ph: 819-820-6480
  Email: crcinformation.chus@ssss.gouv.qc.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00499330
ClinicalTrials.gov processed this data on October 17, 2013

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.