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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	CALGB-140503 CALGB-140503, ECOG-40503, NCT00499330

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 or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration*

   [Note: *Nodes previously sampled by mediastinoscopy either immediately prior to 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 every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 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.
California
	Concord
	Cancer Care Center at John Muir Health - Concord Campus
		Clinical Trials Office - Cancer Care Center at John Muir Health - Concord Campus	Ph:  925-674-2580
	Loma Linda
	Veterans Affairs Medical Center - Loma Linda (Pettis)
		Mark Reeves, MD, PhD	Ph:  909-825-7084ext.6064
	Long Beach
	Veterans Affairs Medical Center - Long Beach
		Amir Abolhoda	Ph:  562-826-5522
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
	Walnut Creek
	John Muir/Mt. Diablo Comprehensive Cancer Center
		Clinical Trials Office - John Muir/Mt. Diablo Comprehensive Cancer Center	Ph:  925-941-4246
Connecticut
	Bridgeport
	St. Vincent's Medical Center
		Albert DiMeo	Ph:  203-576-6000
	Greenwich
	Bendheim Cancer Center at Greenwich Hospital
		Clinical Trials Office - Bendheim Cancer Center	Ph:  203-863-3698
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:  302-733-6227
Florida
	Boca Raton
	Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
		Clinical Trials Office - Eugene M. and Christine E. Lynn Cancer Institute	Ph:  561-955-4800
	Stuart
	Robert and Carol Weissman Cancer Center at Martin Memorial
		James Thornton	Ph:  772-288-5858
		James Thornton	Ph:  772-288-5858
Georgia
	Altanta
	Winship Cancer Institute of Emory University
		Daniel Miller, MD	Ph:  404-778-3755
	Savannah
	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
		Brian Bailey	Ph:  912-819-6000
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Elk Grove Village
	Alexian Brothers Radiation Oncology
		Molly McAfee	Ph:  847-981-5760
	Springfield
	Cancer Institute at St. John's Hospital
		Stephen Hazelrigg, MD	Ph:  217-545-8875
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Simmons Cooper Cancer Institute
		Clinical Trials Office - Simmons Cooper Cancer Institute	Ph:  217-545-7929
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
	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
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kansas
	Overland Park
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Hospital - South
		Rakesh Gaur, MD	Ph:  816-823-0555
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Abbas Abbas, MD	Ph:  614-293-8000
Maine
	Bangor
	CancerCare of Maine at Eastern Maine Medical Center
		Clinical Trials Office - CancerCare of Maine	Ph:  207-973-4274
Maryland
	Baltimore
	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
	Elkton MD
	Union Hospital Cancer Program at Union Hospital
		Thomas Bauer, MD	Ph:  302-623-4530
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
	Dana-Farber/Brigham and Women's Cancer Center
		Clinical Trials Office	Ph:  617-724-5200
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Jon Wee	Ph:  617-632-3474 866-790-4500
	Tufts-NEMC Cancer Center
		Gary Strauss	Ph:  617-636-6100
Michigan
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		S. David Nathanson, MD	Ph:  313-916-2917
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
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Lee's Summit
	Saint Luke's East - Lee's Summit
		Rakesh Gaur, MD	Ph:  816-823-0555
	Liberty
	Liberty Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	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 Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Freehold
	CentraState Medical Center
		Huzaifa Shakir	Ph:  732-431-2000
	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
	East Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
	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
	NYU Cancer Institute at New York University Medical Center
		Harvey Pass, MD	Ph:  212-263-7417
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Daniel Raymond	Ph:  585-275-5345
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
North Carolina
	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 Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Goldsboro
	Southeastern Medical Oncology Center - Goldsboro
		James Atkins, MD	Ph:  919-580-0000
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Pinehurst
	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
		Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Ph:  910-715-2200
Ohio
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	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 Solove Research Institute at Ohio State University Medical 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
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		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
	Mercy Medical Center
		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
	Milwaukie
	Providence Milwaukie Hospital
		Janet Ruzich	Ph:  503-513-8300
	Portland
	Adventist Medical Center
		Janet Ruzich	Ph:  503-257-2500
	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
	Pittsburgh
	Allegheny Cancer Center at Allegheny General Hospital
		Robert Keenan, MD	Ph:  412-359-6202
	UPMC - Shadyside
		Clinical Trials Office - UPMC - Shadyside	Ph:  412-621-2334
	UPMC Cancer Center at Magee-Womens Hospital
		Clinical Trials Office - UPMC Cancer Center at Magee-Womens Hospital	Ph:  412-647-2811
	UPMC Cancer Center at UPMC Passavant
		Clinical Trials Office - UPMC Cancer Center at UPMC Passavant	Ph:  412-367-6454
	UPMC Cancer Center at UPMC Presbyterian
		Clinical Trial Office - UPMC Cancer Center at UPMC Presbyterian	Ph:  412-647-2811
	UPMC Cancer Center at UPMC St. Margaret
		Rodney Landreneau, MD	Ph:  412-623-2025
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		Jason Lamb, MD	Ph:  412-578-1034
	York
	York Cancer Center at Apple Hill Medical Center
		Amit Shah	Ph:  717-741-8180
Rhode Island
	Providence
	Miriam Hospital
		Clinical Trials Office - Miriam Hospital	Ph:  401-793-2224
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
Tennessee
	Knoxville
	U.T. Medical Center Cancer Institute
		Clinical Trials Office - U.T. Medical Center Cancer Institute	Ph:  865-544-9773
Texas
	Dallas
	Medical City Dallas Hospital
		Mitchell Magee	Ph:  972-566-7000
Vermont
	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
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		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
	Polyclinic First Hill
		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
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Janet Ruzich	Ph:  360-514-2174
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Milwaukee
	Froedtert Hospital and Medical College of Wisconsin
		Clinical Trials Office - Froedtert Hospital	Ph:  414-805-3666
Canada
Ontario
	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
	St. Joseph's Health Centre - Toronto
		Christopher Compeau	Ph:  416-530-6000
Quebec
	Quebec
	L'Hopital Laval
		Eric Frechette	Ph:  418-656-4810

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		2009-11-20
NCI Grant/Contract Number		CA31946

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