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

A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: lobectomy; Procedure: segmentectomy or wedge resection

Detailed Description

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 CT 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. For more information, please see the Arms section.

Primary Objective:

To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral (≤ 2 cm) NSCLC.

Secondary Objectives:

1. To determine whether overall survival (OS) (after sublobar resection) is non-inferior to that after lobectomy.
2. To determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection.
3. To determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively.
4. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilarand mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection of small stage IA NSCLC.

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

• Study Type: Interventional
• Enrollment (Actual): 701
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Saint Vincent's Hospital
• Canada
  • Québec, Canada, G1V 4G5
    • University Institute of Cardiology and Pneumology of Quebec (Laval Hospital)
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Surrey Memorial Hospital
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V8
      • QEII Health Sciences Centre/Capital District Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Saint Joseph's Healthcare Charlton Campus
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital and Cancer Center-General Campus
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network-Princess Margaret Hospital
    • Toronto, Ontario, Canada, M6R 1B5
      • Saint Joseph's Health Centre
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM - Hopital Notre-Dame
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Cancer Center
  • Alaska
    • Anchorage, Alaska, United States, 98508
      • Anchorage Associates in Radiation Medicine
    • Anchorage, Alaska, United States, 99508
      • Alaska Breast Care and Surgery LLC
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology LLC
    • Anchorage, Alaska, United States, 99508
      • Alaska Women's Cancer Care
    • Anchorage, Alaska, United States, 99508
      • Anchorage Oncology Centre
    • Anchorage, Alaska, United States, 99508
      • Katmai Oncology Group
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
    • Anchorage, Alaska, United States, 99504
      • Anchorage Radiation Therapy Center
    • Anchorage, Alaska, United States, 99508
      • Alaska Regional Hospital
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
    • Tucson, Arizona, United States, 85724
      • The University of Arizona Medical Center-University Campus
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Mercy Cancer Center-Hot Springs
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
    • Rogers, Arkansas, United States, 72758
      • Highlands Oncology Group-Rogers
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    • Carmichael, California, United States, 95608
      • Mercy San Juan Medical Center
    • Fullerton, California, United States, 92835
      • Saint Jude Medical Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Loma Linda, California, United States, 92357
      • Veterans Affairs Loma Linda Healthcare System
    • Long Beach, California, United States, 90822
      • Veterans Administration Long Beach Medical Center
    • Orange, California, United States, 92868
      • UC Irvine Health/Chao Family Comprehensive Cancer Center
    • Riverside, California, United States, 92505
      • Kaiser Permanente-Riverside
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    • Colorado Springs, Colorado, United States, 80907
      • Penrose-Saint Francis Healthcare
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers-Penrose
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Hospital Colorado Springs
    • Denver, Colorado, United States, 80210
      • Porter Adventist Hospital
    • Denver, Colorado, United States, 80217-3364
      • University of Colorado
    • Durango, Colorado, United States, 81301
      • Mercy Medical Center
    • Durango, Colorado, United States, 81301
      • Southwest Oncology PC
    • Golden, Colorado, United States, 80401
      • Mountain Blue Cancer Care Center
    • Lakewood, Colorado, United States, 80228
      • Saint Anthony Hospital
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers-Lakewood
    • Littleton, Colorado, United States, 80122
      • Littleton Adventist Hospital
    • Longmont, Colorado, United States, 80501
      • Longmont United Hospital
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers-Longmont
    • Parker, Colorado, United States, 80138
      • Parker Adventist Hospital
    • Parker, Colorado, United States, 80138
      • Rocky Mountain Cancer Centers-Parker
    • Pueblo, Colorado, United States, 81004
      • Saint Mary Corwin Medical Center
    • Pueblo, Colorado, United States, 81008
      • Rocky Mountain Cancer Centers - Pueblo
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers-Thornton
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Saint Vincent's Medical Center
    • Hartford, Connecticut, United States, 06105
      • Smilow Cancer Hospital Care Center at Saint Francis
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital/Bennett Cancer Center
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Beebe Medical Center
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Delaware Clinical and Laboratory Physicians PA
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System-Christiana Hospital
    • Newark, Delaware, United States, 19713
      • Christiana Gynecologic Oncology LLC
    • Newark, Delaware, United States, 19713
      • Regional Hematology and Oncology PA
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
    • Seaford, Delaware, United States, 19973
      • Nanticoke Memorial Hospital
    • Wilmington, Delaware, United States, 19801
      • Christiana Care Health System-Wilmington Hospital
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Emory University/Winship Cancer Institute
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical Center
    • Savannah, Georgia, United States, 31404
      • Memorial University Medical Center
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Cancer Care Center-Boise
    • Boise, Idaho, United States, 83712
      • Saint Luke's Mountain States Tumor Institute
    • Caldwell, Idaho, United States, 83605
      • Saint Alphonsus Cancer Care Center-Caldwell
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Medical Center
    • Emmett, Idaho, United States, 83617
      • Walter Knox Memorial Hospital
    • Fruitland, Idaho, United States, 83619
      • Saint Luke's Mountain States Tumor Institute - Fruitland
    • Lewiston, Idaho, United States, 83501
      • Saint Joseph Regional Medical Center
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute-Meridian
    • Meridian, Idaho, United States, 83642
      • Saint Luke's Mountain States Tumor Institute - Meridian
    • Nampa, Idaho, United States, 83686
      • Saint Alphonsus Medical Center-Nampa
    • Nampa, Idaho, United States, 83686
      • Saint Luke's Mountain States Tumor Institute - Nampa
    • Pocatello, Idaho, United States, 83201
      • Portneuf Medical Center
    • Post Falls, Idaho, United States, 83854
      • Kootenai Cancer Center
    • Sandpoint, Idaho, United States, 83864
      • Kootenai Cancer Clinic
    • Twin Falls, Idaho, United States, 83301
      • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • Springfield, Illinois, United States, 62702
      • Saint John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University/Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Sidney and Lois Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • Richard L. Roudebush Veterans Affairs Medical Center
    • Mishawaka, Indiana, United States, 46544
      • Memorial Regional Cancer Center Day Road
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
  • Iowa
    • Clive, Iowa, United States, 50325
      • Mercy Cancer Center-West Lakes
    • Clive, Iowa, United States, 50325
      • Medical Oncology and Hematology Associates-West Des Moines
    • Council Bluffs, Iowa, United States, 51503
      • Alegent Health Mercy Hospital
    • Creston, Iowa, United States, 50801
      • Greater Regional Medical Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
    • Des Moines, Iowa, United States, 50314
      • Medical Oncology and Hematology Associates-Laurel
    • West Des Moines, Iowa, United States, 50266
      • Mercy Medical Center-West Lakes
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Olathe, Kansas, United States, 66061
      • Olathe Cancer Center
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66213
      • Saint Luke's South Hospital
    • Shawnee Mission, Kansas, United States, 66204
      • Shawnee Mission Medical Center-KCCC
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Flaget Memorial Hospital
    • Corbin, Kentucky, United States, 40701
      • Commonwealth Cancer Center-Corbin
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
    • Lexington, Kentucky, United States, 40504
      • Saint Joseph Radiation Oncology Resource Center
    • Lexington, Kentucky, United States, 40509
      • Saint Joseph Hospital East
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
    • Louisville, Kentucky, United States, 40215
      • Saints Mary and Elizabeth Hospital
    • Louisville, Kentucky, United States, 40245
      • Jewish Hospital Medical Center Northeast
    • Shepherdsville, Kentucky, United States, 40165
      • Jewish Hospital Medical Center South
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201
      • University of Maryland/Greenebaum Cancer Center
    • Bel Air, Maryland, United States, 21014
      • Upper Chesapeake Medical Center
    • Elkton, Maryland, United States, 21921
      • Union Hospital of Cecil County
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
    • Pittsfield, Massachusetts, United States, 01201
      • Berkshire Hematology Oncology PC
    • Springfield, Massachusetts, United States, 01107
      • D'Amour Center for Cancer Care
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Memorial Health Care
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0995
      • Saint Joseph Mercy Hospital
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Ann Arbor, Michigan, United States, 48106
      • Michigan Cancer Research Consortium NCORP
    • Brighton, Michigan, United States, 48114
      • Saint Joseph Mercy Brighton
    • Brighton, Michigan, United States, 48114
      • IHA Hematology Oncology Consultants-Brighton
    • Canton, Michigan, United States, 48188
      • IHA Hematology Oncology Consultants-Canton
    • Canton, Michigan, United States, 48188
      • Saint Joseph Mercy Canton Health Center
    • Caro, Michigan, United States, 48723
      • Caro Cancer Center
    • Chelsea, Michigan, United States, 48118
      • Saint Joseph Mercy Chelsea
    • Chelsea, Michigan, United States, 48118
      • IHA Hematology Oncology Consultants-Chelsea
    • Clarkston, Michigan, United States, 48346
      • Hematology Oncology Consultants-Clarkston
    • Clarkston, Michigan, United States, 48346
      • Newland Medical Associates-Clarkston
    • Dearborn, Michigan, United States, 48124
      • Beaumont Hospital-Dearborn
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Saint John Hospital and Medical Center
    • East China Township, Michigan, United States, 48054
      • Great Lakes Cancer Management Specialists-Doctors Park
    • Flint, Michigan, United States, 48502
      • Hurley Medical Center
    • Flint, Michigan, United States, 48532
      • Genesys Regional Medical Center-West Flint Campus
    • Flint, Michigan, United States, 48503
      • Genesee Cancer and Blood Disease Treatment Center
    • Flint, Michigan, United States, 48503
      • Genesee Hematology Oncology PC
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Michigan Breast Specialists-Grosse Pointe Woods
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Lymphoma Clinic of Michigan
    • Jackson, Michigan, United States, 49201
      • Allegiance Health
    • Lansing, Michigan, United States, 48912
      • Sparrow Hospital
    • Livonia, Michigan, United States, 48154
      • Saint Mary Mercy Hospital
    • Livonia, Michigan, United States, 48154
      • Hope Cancer Clinic
    • Macomb, Michigan, United States, 48044
      • Michigan Breast Specialists-Macomb Township
    • Macomb, Michigan, United States, 48044
      • Hematology Oncology Associates East PC
    • Pontiac, Michigan, United States, 48341
      • Saint Joseph Mercy Oakland
    • Pontiac, Michigan, United States, 48341
      • 21st Century Oncology-Pontiac
    • Pontiac, Michigan, United States, 48341
      • Hope Cancer Center
    • Pontiac, Michigan, United States, 48341
      • Newland Medical Associates-Pontiac
    • Port Huron, Michigan, United States, 48060
      • Lake Huron Medical Center
    • Rochester Hills, Michigan, United States, 48309
      • Great Lakes Cancer Management Specialists-Rochester Hills
    • Saginaw, Michigan, United States, 48601
      • Saint Mary's of Michigan
    • Saginaw, Michigan, United States, 48604
      • Oncology Hematology Associates of Saginaw Valley PC
    • Sterling Heights, Michigan, United States, 48312
      • Bhadresh Nayak MD PC-Sterling Heights
    • Warren, Michigan, United States, 48093
      • Saint John Macomb-Oakland Hospital
    • Warren, Michigan, United States, 48093
      • Great Lakes Cancer Management Specialists-Macomb Professional Building
    • Warren, Michigan, United States, 48093
      • Macomb Hematology Oncology PC
    • Warren, Michigan, United States, 48093
      • Michigan Breast Specialists-Warren
    • West Branch, Michigan, United States, 48661
      • Saint Mary's Oncology/Hematology Associates of West Branch
    • Ypsilanti, Michigan, United States, 48106
      • Huron Gastroenterology PC
    • Ypsilanti, Michigan, United States, 48197
      • IHA Hematology Oncology Consultants-Ann Arbor
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Cape Girardeau, Missouri, United States, 63701
      • Southeast Missouri Hospital
    • Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Kansas City, Missouri, United States, 64108
      • Truman Medical Center
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology and Oncology Associates Incorporated
    • Kansas City, Missouri, United States, 64114
      • Saint Joseph Health Center
    • Lee's Summit, Missouri, United States, 64086
      • Saint Luke's East - Lee's Summit
    • Liberty, Missouri, United States, 64068
      • Liberty Radiation Oncology Center
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center
    • Saint Joseph, Missouri, United States, 64507
      • Saint Joseph Oncology Inc
    • St Louis, Missouri, United States, 63136
      • Christian Hospital
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Anaconda, Montana, United States, 59711
      • Community Hospital of Anaconda
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Billings, Montana, United States, 59101
      • Saint Vincent Healthcare
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Hospital
    • Butte, Montana, United States, 59701
      • Saint James Community Hospital and Cancer Treatment Center
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
    • Great Falls, Montana, United States, 59405
      • Benefis Healthcare- Sletten Cancer Institute
    • Great Falls, Montana, United States, 59405
      • Big Sky Oncology
    • Helena, Montana, United States, 59601
      • Saint Peter's Community Hospital
    • Kalispell, Montana, United States, 59901
      • Kalispell Regional Medical Center
    • Missoula, Montana, United States, 59804
      • Community Medical Hospital
    • Missoula, Montana, United States, 59802
      • Saint Patrick Hospital - Community Hospital
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • CHI Health Saint Francis
    • Kearney, Nebraska, United States, 68847
      • CHI Health Good Samaritan
    • Kearney, Nebraska, United States, 68845
      • Heartland Hematology and Oncology
    • Lincoln, Nebraska, United States, 68510
      • Saint Elizabeth Regional Medical Center
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68124
      • Alegent Health Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68122
      • Alegent Health Immanuel Medical Center
    • Omaha, Nebraska, United States, 68130
      • Alegent Health Lakeside Hospital
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center
    • Omaha, Nebraska, United States, 68122
      • Hemotology and Oncology Consultants PC
    • Papillion, Nebraska, United States, 68046
      • Midlands Community Hospital
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Cancer Center at Basking Ridge
    • Brick, New Jersey, United States, 08724
      • Ocean Medical Center
    • Camden, New Jersey, United States, 08103
      • Cooper Hospital University Medical Center
    • Edison, New Jersey, United States, 08818
      • John F Kennedy Medical Center
    • Manahawkin, New Jersey, United States, 08050
      • Southern Ocean County Medical Center
    • Neptune City, New Jersey, United States, 07753
      • Jersey Shore Medical Center
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital-Luckow Pavilion
    • Red Bank, New Jersey, United States, 07701
      • Riverview Medical Center/Booker Cancer Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • Westwood, New Jersey, United States, 07675
      • Valley Health System-Hematology/Oncology
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York-East Syracuse
    • Flushing, New York, United States, 11355
      • The New York Hospital Medical Center of Queens
    • Harrison, New York, United States, 10604
      • Memorial Sloan-Kettering Cancer Center West Harrison
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell University
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Rockville Centre
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Asheville VA Medical Center
    • Clinton, North Carolina, United States, 28328
      • Southeastern Medical Oncology Center-Clinton
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center-Goldsboro
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital
    • Jacksonville, North Carolina, United States, 28546
      • Southeastern Medical Oncology Center-Jacksonville
    • Wilson, North Carolina, United States, 27893
      • Southeastern Medical Oncology Center-Wilson
  • Ohio
    • Bellefontaine, Ohio, United States, 43311
      • Mary Rutan Hospital
    • Canton, Ohio, United States, 44708
      • Mercy Medical Center
    • Chillicothe, Ohio, United States, 45601
      • Adena Regional Medical Center
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital - Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45247
      • TriHealth Cancer Institute-Westside
    • Cincinnati, Ohio, United States, 45255
      • TriHealth Cancer Institute-Anderson
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43219
      • The Mark H Zangmeister Center
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Columbus, Ohio, United States, 43222
      • Mount Carmel Health Center West
    • Columbus, Ohio, United States, 43215
      • Columbus NCI Community Oncology Research Program
    • Delaware, Ohio, United States, 43015
      • Grady Memorial Hospital
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Mount Vernon, Ohio, United States, 43050
      • Knox Community Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Hospital
    • Portsmouth, Ohio, United States, 45662
      • Southern Ohio Medical Center
    • Springfield, Ohio, United States, 45505
      • Springfield Regional Medical Center
    • Westerville, Ohio, United States, 43081
      • Saint Ann's Hospital
    • Youngstown, Ohio, United States, 44501
      • Tod Children's Hospital - Forum Health
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare System Cancer Care Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Baker City, Oregon, United States, 97814
      • Saint Alphonsus Medical Center-Baker City
    • Bend, Oregon, United States, 97701
      • Saint Charles Health System
    • Clackamas, Oregon, United States, 97015
      • Clackamas Radiation Oncology Center
    • Clackamas, Oregon, United States, 97015
      • Providence Oncology and Hematology Care Southeast
    • Coos Bay, Oregon, United States, 97420
      • Bay Area Hospital
    • Milwaukie, Oregon, United States, 97222
      • Providence Milwaukie Hospital
    • Newberg, Oregon, United States, 97132
      • Providence Newberg Medical Center
    • Ontario, Oregon, United States, 97914
      • Saint Alphonsus Medical Center-Ontario
    • Oregon City, Oregon, United States, 97045
      • Providence Willamette Falls Medical Center
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Saint Vincent Medical Center
    • Portland, Oregon, United States, 97239
      • Portland Veterans Administration Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital-Cedar Crest
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Hospital - Muhlenberg
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Kittanning, Pennsylvania, United States, 16201
      • Armstrong Center for Medicine and Health
    • Lewisburg, Pennsylvania, United States, 17837
      • Geisinger Medical Oncology-Lewisburg
    • Monroeville, Pennsylvania, United States, 15146
      • Forbes Hospital
    • Natrona Heights, Pennsylvania, United States, 15065
      • Allegheny Valley Hospital
    • New Castle, Pennsylvania, United States, 16105
      • Jameson Health System North Campus
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-Magee Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute (UPCI)
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC-Shadyside Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-Presbyterian Hospital
    • Pittsburgh, Pennsylvania, United States, 15215
      • UPMC-Saint Margaret
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC-Passavant Hospital
    • Pottsville, Pennsylvania, United States, 17901
      • Geisinger Medical Oncology-Pottsville
    • Reading, Pennsylvania, United States, 19605
      • Penn State Health Saint Joseph Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group PC-Robert Packer Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Easley, South Carolina, United States, 29640
      • Greenville Health System Cancer Institute-Easley
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System Cancer Institute-Butternut
    • Seneca, South Carolina, United States, 29672
      • Greenville Health System Cancer Institute-Seneca
    • Spartanburg, South Carolina, United States, 29307
      • Greenville Health System Cancer Institute-Spartanburg
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Memorial Hospital
    • Hixson, Tennessee, United States, 37343
      • Pulmonary Medicine Center of Chattanooga-Hixson
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee - Knoxville
    • Ooltewah, Tennessee, United States, 37363
      • Memorial GYN Plus
  • Texas
    • Bryan, Texas, United States, 77802
      • Saint Joseph Regional Cancer Center
    • Dallas, Texas, United States, 75390
      • UT Southwestern/Simmons Cancer Center-Dallas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
  • Utah
    • American Fork, Utah, United States, 84003
      • American Fork Hospital / Huntsman Intermountain Cancer Center
  • Vermont
    • Berlin Corners, Vermont, United States, 05602
      • Central Vermont Medical Center/National Life Cancer Treatment
    • Burlington, Vermont, United States, 05405
      • University of Vermont College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center
    • Fredericksburg, Virginia, United States, 22401
      • Mary Washington Hospital
    • Hampton, Virginia, United States, 23666
      • Virginia Oncology Associates-Hampton
    • Hampton, Virginia, United States, 23666
      • Sentara Cancer Institute at Sentara CarePlex Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates - Lake Wright
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center
    • Williamsburg, Virginia, United States, 23188
      • Sentara Williamsburg Regional Medical Center
  • Washington
    • Aberdeen, Washington, United States, 98520
      • Providence Regional Cancer System-Aberdeen
    • Anacortes, Washington, United States, 98221
      • Cancer Care Center at Island Hospital
    • Auburn, Washington, United States, 98001
      • MultiCare Auburn Medical Center
    • Bellevue, Washington, United States, 98005
      • Swedish Cancer Institute-Eastside Oncology Hematology
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Bellingham, Washington, United States, 98225
      • PeaceHealth Saint Joseph Medical Center
    • Bremerton, Washington, United States, 98310
      • Harrison HealthPartners Hematology and Oncology-Bremerton
    • Bremerton, Washington, United States, 98310
      • Harrison Medical Center
    • Burien, Washington, United States, 98166
      • Highline Medical Center-Main Campus
    • Centralia, Washington, United States, 98531
      • Providence Regional Cancer System-Centralia
    • Edmonds, Washington, United States, 98026
      • Swedish Medical Center-Edmonds
    • Enumclaw, Washington, United States, 98022
      • Saint Elizabeth Hospital
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Federal Way, Washington, United States, 98003
      • Saint Francis Hospital
    • Issaquah, Washington, United States, 98029
      • Swedish Cancer Institute-Issaquah
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic Hematology and Oncology
    • Kirkland, Washington, United States, 98034
      • Seattle Cancer Care Alliance at EvergreenHealth
    • Lacey, Washington, United States, 98503
      • Providence Regional Cancer System-Lacey
    • Lakewood, Washington, United States, 98499
      • Saint Clare Hospital
    • Longview, Washington, United States, 98632
      • PeaceHealth Saint John Medical Center
    • Mount Vernon, Washington, United States, 98274
      • Skagit Valley Hospital
    • Olympia, Washington, United States, 98506-5166
      • Providence - Saint Peter Hospital
    • Poulsbo, Washington, United States, 98370
      • Harrison HealthPartners Hematology and Oncology-Poulsbo
    • Puyallup, Washington, United States, 98372
      • MultiCare Good Samaritan Hospital
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98107
      • Swedish Medical Center-Ballard Campus
    • Seattle, Washington, United States, 98104
      • Minor and James Medical PLLC
    • Seattle, Washington, United States, 98104
      • Pacific Gynecology Specialists
    • Seattle, Washington, United States, 98112
      • Group Health Cooperative-Seattle
    • Seattle, Washington, United States, 98122-4307
      • Swedish Medical Center-First Hill
    • Sedro-Woolley, Washington, United States, 98284
      • United General Hospital
    • Shelton, Washington, United States, 98584
      • Providence Regional Cancer System-Shelton
    • Spokane, Washington, United States, 99204
      • Rockwood Cancer Treatment Center-DHEC-Downtown
    • Spokane, Washington, United States, 99218
      • Evergreen Hematology and Oncology PS
    • Spokane, Washington, United States, 99202
      • Cancer Care Northwest - Spokane South
    • Spokane, Washington, United States, 99220
      • Rockwood Clinic
    • Spokane, Washington, United States, 99218
      • Rockwood North Cancer Treatment Center
    • Spokane Valley, Washington, United States, 99216
      • Rockwood Clinic Cancer Treatment Center-Valley
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties PLLC
    • Tacoma, Washington, United States, 98405
      • MultiCare Tacoma General Hospital
    • Tacoma, Washington, United States, 98405
      • Franciscan Research Center-Northwest Medical Plaza
    • Tacoma, Washington, United States, 98405
      • MultiCare Allenmore Hospital
    • Tacoma, Washington, United States, 98405
      • Saint Joseph Medical Center
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical Center
    • Vancouver, Washington, United States, 98684
      • Compass Oncology Vancouver
    • Walla Walla, Washington, United States, 99362
      • Providence Saint Mary Regional Cancer Center
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital and Clinics
    • Yakima, Washington, United States, 98902
      • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Yelm, Washington, United States, 98597
      • Providence Regional Cancer System-Yelm
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • Fox Valley Surgical Associates Limited
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and the Medical College of Wisconsin
  • Wyoming
    • Cody, Wyoming, United States, 82414
      • Big Horn Basin Cancer Center
    • Cody, Wyoming, United States, 82414
      • Billings Clinic-Cody
    • Sheridan, Wyoming, United States, 82801
      • Welch Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Pre-registration Eligibility Criteria:

1. Peripheral lung nodule ≤ 2 cm on preoperative CT scan and presumed to be lung cancer. The center of the tumor, as seen on CT, must be located in the outer third of the lung in either the transverse, coronal or sagittal plane. Patients with pure ground glass opacities or pathologically confirmed N1 or N2 disease are not eligible.
2. The tumor location must be suitable for either lobar or sublobar resection (wedge or segment).
3. ECOG performance status of 0-2.
4. No prior malignancy within 3 years other than non-melanoma skin cancer, superficial bladder cancer, or CIS of the cervix.
5. No prior chemotherapy or radiation therapy for this malignancy.
6. No evidence of locally advanced or metastatic disease.
7. Age ≥ 18 years

Intra-operative Randomization Eligibility Criteria:

1. Histologic confirmation of NSCLC (if not already obtained)
2. Confirmation of N0 status by frozen section examination. Right sided tumors require that node levels 4, 7, and 10 be sampled and diagnosed as negative on frozen section. Left sided tumors require that node levels 5 or 6, 7 and 10 be sampled and diagnosed as negative on frozen section. 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 VATS exploration. Nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm A; Patients undergo a standard operation for lung cancer called a lobectomy.	Procedure: lobectomy
Experimental: Arm B; Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.	Procedure: segmentectomy or wedge resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	Up to 7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	Up to 7 years
rate of loco-regional and systemic recurrence	Up to 7 years
pulmonary function as measured by expiratory flow rate 6 months postoperatively	at 6 months

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Nasser Altorki, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Altorki NK, Wang X, Wigle D, Gu L, Darling G, Ashrafi AS, Landrenau R, Miller D, Liberman M, Jones DR, Keenan R, Conti M, Wright G, Veit LJ, Ramalingam SS, Kamel M, Pass HI, Mitchell JD, Stinchcombe T, Vokes E, Kohman LJ. Perioperative mortality and morbidity after sublobar versus lobar resection for early-stage non-small-cell lung cancer: post-hoc analysis of an international, randomised, phase 3 trial (CALGB/Alliance 140503). Lancet Respir Med. 2018 Dec;6(12):915-924. doi: 10.1016/S2213-2600(18)30411-9. Epub 2018 Nov 12.
• Stinchcombe TE, Wang X, Damman B, Mentlick J, Landreneau R, Wigle D, Jones DR, Conti M, Ashrafi AS, Liberman M, de Perrot M, Mitchell JD, Keenan R, Bauer T, Miller D, Altorki N. Secondary Analysis of the Rate of Second Primary Lung Cancer From Cancer and Leukemia Group B 140503 (Alliance) Trial of Lobar Versus Sublobar Resection for T1aN0 Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Apr 1;42(10):1110-1113. doi: 10.1200/JCO.23.01306. Epub 2024 Jan 12.
• Altorki N, Wang X, Kozono D, Watt C, Landrenau R, Wigle D, Port J, Jones DR, Conti M, Ashrafi AS, Liberman M, Yasufuku K, Yang S, Mitchell JD, Pass H, Keenan R, Bauer T, Miller D, Kohman LJ, Stinchcombe TE, Vokes E. Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Feb 9;388(6):489-498. doi: 10.1056/NEJMoa2212083.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2007
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimated): July 11, 2007

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; stage IA non-small cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Surgical Procedures, Operative; Mastectomy; Neurosurgical Procedures; Mastectomy, Segmental; Anterior Temporal Lobectomy
• Other Study ID Numbers: CALGB 140503; CALGB-140503; CDR0000555324 (Registry Identifier: NCI Physician Data Query); NCI-2009-00447 (Registry Identifier: NCI Clinical Trial Reporting Program)