Trial record 1 of 1 for:    ACOSOG Z4099
Previous Study | Return to List | Next Study

Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01336894
First received: April 15, 2011
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known whether stereotactic body radiation therapy is more effective than surgery with or without internal radiation therapy in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well surgery with or without internal radiation therapy works compared with stereotactic body radiation therapy in treating patients with high-risk stage IA or stage IB non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Procedure: therapeutic conventional surgery
Radiation: iodine I 125
Radiation: stereotactic body radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Sublobar Resection (+/- Brachytherapy) Versus Stereotactic Body Radiation Therapy in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 5-year OS rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loco-regional recurrence-free survival [ Designated as safety issue: No ]
  • Adverse event profiles at 1, 3, 6, and 12 months post-therapy [ Designated as safety issue: Yes ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Pulmonary function test values [ Designated as safety issue: Yes ]
  • Overall quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: May 2011
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo sublobar resection comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedure: therapeutic conventional surgery
Undergo surgery
Radiation: iodine I 125
Undergo seed implant radiotherapy
Experimental: Arm II
Patients undergo 3 fractions of stereotactic body radiation therapy at 2-8 days apart.
Radiation: stereotactic body radiation therapy
Undergo radiotherapy

  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Lung nodule suspicious for non-small cell lung cancer (NSCLC)

    • Biopsy confirmation is strongly recommended but not required; if biopsy is attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of biopsy is considered too high, patients may be enrolled if the mass is suspicious for NSCLC based on two or more of the following criteria:

      • Positive smoking history
      • Absence of benign calcifications within suspicious nodule
      • Activity on PET greater than normal tissue
      • Evidence of growth compared to previous imaging
      • Presence of spiculation
  • Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration
  • All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration, CT-guided, or video-assisted thoracoscopic or open lymph node biopsy
  • Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection
  • Tumor located peripherally within the lung, defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions

    • Patients with non-peripheral (central) tumors are NOT eligible
  • No evidence of distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0, 1, or 2
  • Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:

    • Major criteria

      • FEV1 ≤ 50% predicted
      • DLCO ≤ 50% predicted
    • Minor criteria

      • Age ≥ 75 years
      • FEV1 51-60% predicted
      • DLCO 51-60% predicted
      • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
      • Poor left ventricular function (defined as an ejection fraction of 40% or less)
      • Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%
      • pCO2 > 45 mm Hg
      • Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3
  • Not pregnant or nursing
  • Negative urine or serum pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration (except non-melanoma skin cancer, in-situ cancers).

PRIOR CONCURRENT THERAPY:

  • No prior intra-thoracic radiotherapy

    • Prior radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted
  • Prior chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336894

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center    205-934-0309      
United States, Arizona
Mayo Clinic Hospital Recruiting
Phoeniz, Arizona, United States, 85054
Contact: Francis C. Nichols, III    480-515-6296      
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer    916-734-3089      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center    650-498-7061    cctoffice@stanford.edu   
United States, Florida
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Justin Rineer    407-648-3800      
United States, Georgia
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Daniel L. Miller, MD    404-778-3755      
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute    404-778-1900      
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer    912-350-8568      
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    309-655-2000      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Neal E. Dunlap    502-562-4158      
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Stephen M. Cattaneo, II    443-481-5800      
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      
St. Agnes Hospital Cancer Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard S. Hudes, MD    410-368-2965      
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen    617-638-8265      
Tufts Medical Center Cancer Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Kathryn E. Huber    617-636-6100      
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive    800-865-1125      
William Beaumont Hospital - Royal Oak Campus Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak    248-551-7695      
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Traves D. Crabtree    314-747-7222      
United States, New Jersey
Valley Hospital - Ridgewood Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Robert J. Korst    201-634-5339      
United States, New York
St. Luke's - Roosevelt Hospital Center - St.Luke's Division Recruiting
New York, New York, United States, 10025
Contact: Cliff P. Connery, MD    212-523-7475      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Yuhchyau Chen    585-275-5345      
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center    800-862-2215      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Sandra L. Starnes    513-584-3200      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
Allegheny Cancer Center at Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Robert J. Keenan, MD    412-359-6202      
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amit B. Shah    717-741-8180      
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni    843-792-9321      
United States, Texas
Baylor University Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Clinical Trials Office - Baylor University Medical Center - Da    800-422-9567      
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673; 214-648-7097      
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Benjamin D. Kozower    434-924-9333      
Sentara Cancer Institute at Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Clinical Trials Office - Sentara Cancer Institute at Sentara N    757-388-2406      
United States, Washington
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Yoshio Inoue    425-297-5500      
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Brian E. Louie    206-386-2323      
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Veterans Affairs Medical Center - Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Elizabeth M. Gore, MD    414-805-4369      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Richard A. Malthaner    519-685-8615      
Ottawa Hospital Regional Cancer Centre - General Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Sebastien Gilbert    613-737-7700 ext. 70209      
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Byoung-Chun J. Cho    416-946-2811      
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Moishe Liberman    514-281-6000      
Sponsors and Collaborators
American College of Surgeons
Investigators
Principal Investigator: Hiran C. Fernando, MD Boston Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT01336894     History of Changes
Other Study ID Numbers: CDR0000698986, ACOSOG-Z4099
Study First Received: April 15, 2011
Last Updated: February 14, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014