Trial record 1 of 1 for:    CALGB 140503
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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00499330
First received: July 10, 2007
Last updated: August 28, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: lobectomy
Procedure: segmentectomy or wedge resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small (≤ 2 cm) Peripheral Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • rate of loco-regional and systemic recurrence [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • pulmonary function as measured by expiratory flow rate 6 months postoperatively [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1258
Study Start Date: June 2007
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499330

Contacts
Contact: Nasser Altorki, MD 212 746-5156

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Matthew Steliga, MD    501-686-7884      
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: David Cooke, MD    916-734-3861      
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: John Mitchell, MD    303-724-2800      
United States, Connecticut
St. Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
Contact: Albert C. DiMeo    203-576-6000      
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Brian Taikwoo Nam, MD    302-623-4530      
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Brian Taikwoo Nam, MD    302-623-4530      
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael Schwartz, MD    305-535-3310      
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Phillip Stella, MD    734-712-1000      
United States, Illinois
NorthShore University HealthSystem-Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: John Howington, MD    847-570-1632      
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Thomas Birdas, MD    317-274-7728      
Richard L. Roudebush Veterans Affairs Medical Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Thomas J. Birdas, MD    317-274-7728      
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Brian Pettiford, MD    504-842-3966      
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit    800-888-8823      
Veterans Affairs Medical Center - Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Richard J. Battafarano, MD, PhD    410-328-6366      
Upper Chesapeake Medical Center Recruiting
Bel Air, Maryland, United States, 21014
Contact: Richard J. Battafarano, MD, PhD    410-328-6366      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Thomas L. Bauer, MD    302-623-4530      
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Bryan Steinberg, MD    301-270-2844      
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip Stella, MD    734-712-1000      
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Andrew Chang, MD    734-763-7418      
Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip Stella, MD    734-712-1000      
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip Stella, MD    734-712-1000      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip Stella, MD    734-712-1000      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Philip Stella, MD    734-712-1000      
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Philip J. Stella, MD    734-712-1000      
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip Stella, MD    734-712-1000      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip Stella, MD    734-712-1000      
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip Stella, MD    734-712-1000      
Saint John Macomb-Oakland Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Dennis Wigle, MD    507-284-8462      
United States, New Jersey
Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Benjamin E. Lee, MD    201-634-5339      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Chukwumere Nwogu, MD    716-845-5873      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Leslie Kohman, MD    315-464-6303      
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeffrey Crawford, MD    919-681-9509      
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
United States, Ohio
Mercy Medical Center Recruiting
Canton, Ohio, United States, 44708
Contact: Mitchell Haut, MD    330-453-9993      
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Robert Merritt, MD    614-293-9059      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Keith Lanier, MD    503-216-6300      
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Keith Lanier, MD    503-216-6300      
Providence Willamette Falls Medical Center Recruiting
Oregon City, Oregon, United States, 97045
Contact: Keith Lanier, MD    503-216-6300      
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Keith Lanier, MD    503-216-6300      
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Keith Lanier, MD    503-216-6300      
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Matthew Facktor, MD    570-214-1991      
Forbes Hospital Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Rodney Landreneau, MD    412-359-6202      
Jameson Memorial Hospital - North Campus Recruiting
New Castle, Pennsylvania, United States, 16105
Contact: Rodney J. Landreneau, MD    412-623-2025      
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Walter Scott, MD    215-214-1427      
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Rodney Landreneau, MD    412-359-6202      
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Matthew Schuchert, MD    412-647-7555      
United States, Tennessee
University of Tennessee - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Thomas Gaines, MD    865-637-6392      
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Benjamin D. Kozower    434-924-9333      
United States, Washington
Highline Medical Center-Main Campus Recruiting
Burien, Washington, United States, 98166
Contact: Joseph Verdirame, MD    402-572-3535      
Saint Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Joseph Verdirame, MD    402-572-3535      
Harrison HealthPartners Hematology and Oncology-Poulsbo Recruiting
Poulsbo, Washington, United States, 98370
Contact: Joseph Verdirame, MD    402-572-3535      
Group Health Cooperative-Seattle Recruiting
Seattle, Washington, United States, 98112
Contact: Keith Lanier, MD    503-216-6300      
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Keith Lanier, MD    503-216-6300      
Canada, British Columbia
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Ahmad S. Ashrafi    604-581-2211      
Canada, Ontario
Saint Joseph's Healthcare Charlton Campus Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Yaron Shargall, MD    905-522-4941      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Richard A. Malthaner, MD    519-685-8615      
Ottawa Hospital and Cancer Center-General Campus Recruiting
Ottawa, Ontario, Canada, K1H 1C4
Contact: Andrew J.E. Seely, MD    613-737-7700 ext 70209      
Canada, Quebec
CHUM - Hopital Notre-Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Moishe Liberman, MD    514-281-6000      
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Marco Sirois, MD    819-346-1110      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Nasser Altorki, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00499330     History of Changes
Other Study ID Numbers: CALGB-140503, CALGB-140503, CDR0000555324
Study First Received: July 10, 2007
Last Updated: August 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer
large cell lung cancer
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2015