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Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases (NCT00003724)

National Cancer Institute (NCI)
RATIONALE: Video-assisted surgery may have fewer side effects than conventional surgery in patients with lung metastases. It is not yet known whether conventional surgery or video-assisted surgery is more effective in treating lung metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with that of video-assisted surgery in treating patients who have lung metastases.
  • Procedure: surgical procedure
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Compare the overall survival and failure free survival of patients with isolated pulmonary metastases treated with minimally invasive (video assisted) resection or open resection. II. Compare patterns of recurrence in these patients after these treatments, and determine what factors are predictive of recurrence. III. Describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy in these patients. IV. Test whether the patients undergoing video-assisted thoracic surgery will have a significantly better quality of life over a six month period than those undergoing an open resection.

    OUTLINE: This is a randomized study. Patients are stratified according to histology (sarcoma vs epithelial vs germ cell vs melanoma) and disease laterality. After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with curative intent, patients are randomized to undergo either open resection (thoracotomy, median sternotomy, or bilateral sternothoracotomy) (arm I) or minimally-invasive video-assisted resection (arm II). Patients with isolated recurrence in the chest should have the recurrence(s) resected if feasible. The original resection approach (open versus VATS) should be the preferred method for the second resection, but is not required. Quality of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

    PROJECTED ACCRUAL: There will be 530 patients accrued into this study in approximately 3 years.

    45 locations

    United States (45)
    • University of California San Diego Cancer Center
      Not specified
      La Jolla, California, United States, 92093-0658
    • UCSF Cancer Center and Cancer Research Institute
      Not specified
      San Francisco, California, United States, 94115-0128
    • Veterans Affairs Medical Center - San Francisco
      Not specified
      San Francisco, California, United States, 94121
    • CCOP - Christiana Care Health Services
      Not specified
      Wilmington, Delaware, United States, 19899
    • Lombardi Cancer Center, Georgetown University
      Not specified
      Washington, District of Columbia, United States, 20007
    • Walter Reed Army Medical Center
      Not specified
      Washington, District of Columbia, United States, 20307-5000
    • CCOP - Mount Sinai Medical Center
      Not specified
      Miami Beach, Florida, United States, 33140
    • University of Illinois at Chicago Health Sciences Center
      Not specified
      Chicago, Illinois, United States, 60612
    • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      Not specified
      Chicago, Illinois, United States, 60612
    • University of Chicago Cancer Research Center
      Not specified
      Chicago, Illinois, United States, 60637
    • University of Iowa Hospitals and Clinics
      Not specified
      Iowa City, Iowa, United States, 52242
    • Veterans Affairs Medical Center - Togus
      Not specified
      Togus, Maine, United States, 04330
    • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
      Not specified
      Baltimore, Maryland, United States, 21201
    • Dana-Farber Cancer Institute
      Not specified
      Boston, Massachusetts, United States, 02115
    • University of Massachusetts Memorial Medical Center
      Not specified
      Worcester, Massachusetts, United States, 01655
    • Veterans Affairs Medical Center - Minneapolis
      Not specified
      Minneapolis, Minnesota, United States, 55417
    • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      Not specified
      Columbia, Missouri, United States, 65201
    • Ellis Fischel Cancer Center - Columbia
      Not specified
      Columbia, Missouri, United States, 65203
    • University of Missouri
      Not specified
      Columbia, Missouri, United States, 65212
    • Barnes-Jewish Hospital
      Not specified
      Saint Louis, Missouri, United States, 63110
    • University of Nebraska Medical Center
      Not specified
      Omaha, Nebraska, United States, 68198-3330
    • CCOP - Southern Nevada Cancer Research Foundation
      Not specified
      Las Vegas, Nevada, United States, 89106
    • Norris Cotton Cancer Center
      Not specified
      Lebanon, New Hampshire, United States, 03756
    • Veterans Affairs Medical Center - Buffalo
      Not specified
      Buffalo, New York, United States, 14215
    • CCOP - North Shore University Hospital
      Not specified
      Manhasset, New York, United States, 11030
    • North Shore University Hospital
      Not specified
      Manhasset, New York, United States, 11030
    • Memorial Sloan-Kettering Cancer Center
      Not specified
      New York, New York, United States, 10021
    • New York Presbyterian Hospital - Cornell Campus
      Not specified
      New York, New York, United States, 10021
    • Mount Sinai Medical Center, NY
      Not specified
      New York, New York, United States, 10029
    • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      Not specified
      Syracuse, New York, United States, 13210
    • State University of New York - Upstate Medical University
      Not specified
      Syracuse, New York, United States, 13210
    • Veterans Affairs Medical Center - Syracuse
      Not specified
      Syracuse, New York, United States, 13210
    • Lineberger Comprehensive Cancer Center, UNC
      Not specified
      Chapel Hill, North Carolina, United States, 27599-7295
    • Veterans Affairs Medical Center - Durham
      Not specified
      Durham, North Carolina, United States, 27705
    • Duke Comprehensive Cancer Center
      Not specified
      Durham, North Carolina, United States, 27710
    • CCOP - Southeast Cancer Control Consortium
      Not specified
      Winston-Salem, North Carolina, United States, 27104-4241
    • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      Not specified
      Winston-Salem, North Carolina, United States, 27157-1082
    • Arthur G. James Cancer Hospital - Ohio State University
      Not specified
      Columbus, Ohio, United States, 43210
    • Rhode Island Hospital
      Not specified
      Providence, Rhode Island, United States, 02903
    • Medical University of South Carolina
      Not specified
      Charleston, South Carolina, United States, 29425-0721
    • University of Tennessee, Memphis Cancer Center
      Not specified
      Memphis, Tennessee, United States, 38103
    • Veterans Affairs Medical Center - Memphis
      Not specified
      Memphis, Tennessee, United States, 38104
    • Veterans Affairs Medical Center - White River Junction
      Not specified
      White River Junction, Vermont, United States, 05009
    • Veterans Affairs Medical Center - Richmond
      Not specified
      Richmond, Virginia, United States, 23249
    • MBCCOP - Massey Cancer Center
      Not specified
      Richmond, Virginia, United States, 23298-0037
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    10 July, 2016
    Participants:
    530
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