Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

1. 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

1. Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
2. Compare the rates of loco-regional and systemic recurrence in patients undergoing lobectomy vs sublobar resection.
3. Compare the pulmonary function of these patients, as measured by expiratory flow rates at 6 months postoperatively.
4. 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.
5. Determine the false-negative rate of preoperative PET scan for identification of involved hilar and mediastinal lymph nodes.
6. Assess the utility of annual follow-up CT scan after surgical resection in these patients.

Entry 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

Prior/Concurrent Therapy:

• No prior chemotherapy or radiotherapy for this malignancy

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

Expected Enrollment

Outcomes

Disease-free survival

Overall survival
Rate of loco-regional and systemic recurrence
Pulmonary function as measured by expiratory flow rate 6 months postoperatively

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Nasser Altorki, MD, Protocol chair		Ph: 212-746-5156 Email: nkaltork@med.cornell.edu

Radiation Therapy Oncology Group

Harvey Pass, MD, Protocol chair		Ph: 212-263-7417 Email: harvey.pass@med.nyu.edu

American College of Surgeons Oncology Group

Daniel Miller, MD, Protocol chair		Ph: 404-778-3755 Email: daniel_miller@emoryhealth.org

Southwest Oncology Group

Kemp Kernstine, MD, PhD, Protocol chair		Ph: 319-356-3407 Email: kemp-kernstine@uiowa.edu

U.S.A.
Alabama
	Birmingham
	UAB Comprehensive Cancer Center
		Clinical Trials Office - UAB Comprehensive Cancer Center	Ph:  205-934-0309
California
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center	Ph:  858-822-5354
			Email: cancercto@ucsd.edu
	Loma Linda
	Veterans Affairs Medical Center - Loma Linda (Pettis)
		Mark Reeves, MD, PhD	Ph:  909-825-7084ext.6064
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
		Clinical Trials Office - Chao Family Comprehensive Cancer Center	Ph:  877-UC-STUDY
			Email: ucstudy@uci.edu
	Pasadena
	Huntington Cancer Center at Huntington Hospital
		Clinical Trials Office - Huntington Cancer Center	Ph:  626-535-2420
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
Connecticut
	Bridgeport
	St. Vincent's Medical Center
		Albert DiMeo	Ph:  203-576-6000
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
	New Haven
	Yale Cancer Center
		Clinical Trials Office - Yale Cancer Center	Ph:  203-785-5702
Delaware
	Lewes
	Tunnell Cancer Center at Beebe Medical Center
		Clinical Trials Office - Tunnell Cancer Center	Ph:  302-645-3171
	Newark
	CCOP - Christiana Care Health Services
		Clinical Trial Office - CCOP - Christiana Care Health Services	Ph:  302-623-4450
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Hollywood
	Memorial Cancer Institute at Memorial Regional Hospital
		Clinical Trials Office - Memorial Cancer Institute	Ph:  954-985-3443
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Michael Schwartz, MD	Ph:  305-535-3310
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Clinical Trials Office - Winship Cancer Institute	Ph:  404-778-1900
	Decatur
	Veterans Affairs Medical Center - Atlanta (Decatur)
		Maria Jose Amarar Ribeiro	Ph:  404-728-7680
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	Veterans Affairs Medical Center - Indianapolis
		Thomas Birdas	Ph:  317-554-0000 888-878-6889
	William N. Wishard Memorial Hospital
		Thomas Birdas	Ph:  317-639-6671
Kansas
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Luke's Hospital - South
		Rakesh Gaur, MD	Ph:  913-948-5588
	Prairie Village
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  913-948-5588
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Owensboro
	Mitchell Memorial Cancer Center at Owensboro Medical Health System
		Alan Mullins	Ph:  270-688-3600 800-947-7102
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Abbas Abbas, MD	Ph:  614-293-8000
Maryland
	Baltimore
	Greater Baltimore Medical Center Cancer Center
		Clinical Trials Office - Greater Baltimore Medical Center Cancer Center	Ph:  443-849-3706
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
	Veterans Affairs Medical Center - Baltimore
		Richard Battafarano, MD, PhD	Ph:  410-328-6366
	Elkton MD
	Union Hospital of Cecil County
		Thomas Bauer, MD	Ph:  302-623-4530
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-638-8265
	Worcester
	UMASS Memorial Cancer Center - University Campus
		Karl Uy	Ph:  508-856-0011
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Blanc
	Genesys Regional Medical Center
		Philip Stella, MD	Ph:  734-712-1000
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Kansas City
	Heartland Hematology Oncology Associates, Incorporated
		Rakesh Gaur, MD	Ph:  913-948-5588
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  913-948-5588
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  913-948-5588
	Research Medical Center
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  913-948-5588
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  913-948-5588
	Lee's Summit
	Saint Luke's East - Lee's Summit
		Rakesh Gaur, MD	Ph:  913-948-5588
	Liberty
	Liberty Hospital
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Joseph Oncology, Incorporated
		Rakesh Gaur, MD	Ph:  913-948-5588
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Traves Crabtree	Ph:  314-747-7222 800-600-3606
Montana
	Great Falls
	Big Sky Oncology
		Clinical Trial Office - Big Sky Oncology	Ph:  406-731-8217
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
	New York
	New York Weill Cornell Cancer Center at Cornell University
		Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University	Ph:  212-746-1848
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	Asheville
	Veterans Affairs Medical Center - Asheville
		John Lucke, MD	Ph:  828-299-2540
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
Ohio
	Canton
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut, MD	Ph:  330-453-9993
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mount Vernon
	Knox Community Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Portsmouth
	Southern Ohio Medical Center Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oregon
	Clackamas
	Clackamas Radiation Oncology Center
		Janet Ruzich	Ph:  503-513-3300
	Milwaukie
	Providence Milwaukie Hospital
		Janet Ruzich	Ph:  503-513-8300
	Newberg
	Providence Newberg Medical Center
		Janet Ruzich	Ph:  503-537-1555
	Oregon City
	Willamette Falls Hospital
		Janet Ruzich	Ph:  503-650-6758
	Portland
	CCOP - Columbia River Oncology Program
		Janet Ruzich	Ph:  503-216-6260
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
Pennsylvania
	Bethlehem
	St. Luke's Cancer Network at St. Luke's Hospital
		William Burfeind, Jr.	Ph:  610-954-3580
	New Castle
	Jameson Memorial Hospital - North Campus
		Rodney Landreneau, MD	Ph:  412-623-2025
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Pittsburgh
	Allegheny Cancer Center at Allegheny General Hospital
		Robert Keenan, MD	Ph:  412-359-6202
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
Tennessee
	Knoxville
	U.T. Medical Center Cancer Institute
		Clinical Trials Office - U.T. Medical Center Cancer Institute	Ph:  865-544-9773
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Dallas
	Medical City Dallas Hospital
		Mitchell Magee	Ph:  972-566-7000
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
Vermont
	Berlin
	Mountainview Medical
		Bruce Leavitt, MD	Ph:  802-847-4044
	Burlington
	Fletcher Allen Health Care - University Health Center Campus
		Clinical Trials Office - Fletcher Allen Health Care	Ph:  802-656-8990
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Benjamin Kozower	Ph:  434-924-9333 800-223-9173
Washington
	Anacortes
	Island Hospital Cancer Care Center at Island Hospital
		Saul Rivkin, MD	Ph:  206-386-2441
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Burien
	Highline Medical Center Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2441
	Mount Vernon
	Skagit Valley Hospital Cancer Care Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Poulsbo
	Harrison Poulsbo Hematology and Onocology
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Minor and James Medical, PLLC
		Saul Rivkin, MD	Ph:  206-386-2441
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Sedro-Woolley
	North Puget Oncology at United General Hospital
		Saul Rivkin, MD	Ph:  206-386-2441
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Evergreen Hematology and Oncology, PS
		Saul Rivkin, MD	Ph:  206-386-2441
	Vancouver
	Northwest Cancer Specialists at Vancouver Cancer Center
		Janet Ruzich	Ph:  360-944-9889
	Southwest Washington Medical Center Cancer Center
		Janet Ruzich	Ph:  360-514-2174
	Wenatchee
	Wenatchee Valley Medical Center
		Clinical Trials Office - Wenatchee Valley Medical Center	Ph:  509-665-5800
Canada
British Columbia
	Surrey
	Surrey Memorial Hospital
		Ahmad Ashrafi	Ph:  604-581-2211
New Brunswick
	Moncton
	Moncton Hospital
		Paul Dubois	Ph:  506-857-5111
Ontario
	Hamilton
	St. Joseph's Hospital - Charlton Campus
		John Miller, MD	Ph:  905-521-6126
	London
	London Regional Cancer Program at London Health Sciences Centre
		Richard Malthaner	Ph:  519-685-8615
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Andrew Seely	Ph:  613-737-7700 ext. 70209 888-627-5346
	Toronto
	Princess Margaret Hospital
		Marc de Perrot	Ph:  416-946-2811
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Moishe Liberman	Ph:  514-281-6000
	Maisonneuve-Rosemont Hospital
		Gilles Beauchamp	Ph:  514-252-3400
	Quebec
	L'Hopital Laval
		Eric Frechette	Ph:  418-656-4810
	Sherbrooke
	CHUS-Hopital Fleurimont
		Marco Sirois	Ph:  819-346-1110

Related Information

Featured trial article

Registry Information
Official Title		A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 CM) Peripheral Non-Small Cell Lung Cancer
Trial Start Date		2007-06-15
Trial Completion Date		2012-04-17 (estimated)
Registered in ClinicalTrials.gov		NCT00499330
Date Submitted to PDQ		2007-06-11
Information Last Verified		2012-02-10
NCI Grant/Contract Number		CA31946

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