Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Start Date
4/1/2022
Completion Date
3/31/2031
Summary
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. SECONDARY OBJECTIVES: I. To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma. II. To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma. EXPLORATORY OBJECTIVES: I. To compare 30-day rates of perioperative surgical complications for both open surgical resection and thoracoscopy. II. To compare patterns of recurrence (ipsilateral and/or contralateral) in patients who undergo open or thoracoscopic resection for unilateral or bilateral pulmonary metastases. III. To describe the use of localization techniques and its relationship with both surgical approach and pathologic findings. IV. To assess the prognostic significance of a decision to change the post-operative treatment plan. V. To describe the relationship between the preoperative chest computed tomography (CT) imaging, intraoperative surgical findings, and pathologic results, comparing radiological features to the presence of viable tumor. VI. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma. VII. To collect and bank pulmonary metastatic lesions (including frozen tissues and paired metastatic lesions coming from the same patient) to facilitate study of metastatic disease and serial blood samples for future tumor profiling, germline and circulating tumor deoxyribonucleic acid (DNA) studies. OUTLINE: Patients are randomized into 1 of 2 arms. ARM A: Patients undergo open thoracic surgery (thoracotomy). ARM B: Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). All patients undergo computed tomography (CT) throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial. After completion of study treatment, patients are followed up at 7-14 days, 4-6 weeks, and 3 months post-surgery and then every 3 months for up to 2 years.
Eligibility Criteria
Age Range: No minimum to 50 years
Interventions
Biospecimen Collection
Computed Tomography
Questionnaire Administration
Thoracoscopy
Thoracotomy
Conditions
Locations
Children's Hospital of Alabama
Birmingham, Alabama 35233
United States
Providence Alaska Medical Center
Anchorage, Alaska 99508
United States
Kingman Regional Medical Center
Kingman, Arizona 86401
United States
Banner Children's at Desert
Mesa, Arizona 85202
United States
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202-3591
United States
Kaiser Permanente-Anaheim
Anaheim, California 92806
United States
PCR Oncology
Arroyo Grande, California 93420
United States
Kaiser Permanente-Bellflower
Bellflower, California 90706
United States
Kaiser Permanente Downey Medical Center
Downey, California 90242
United States
Kaiser Permanente-Fontana
Fontana, California 92335
United States
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Miller Children's and Women's Hospital Long Beach
Long Beach, California 90806
United States
Children's Hospital Los Angeles
Los Angeles, California 90027
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Valley Children's Hospital
Madera, California 93636
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Children's Hospital of Orange County
Orange, California 92868
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California 94304
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Kaiser Permanente-San Diego Zion
San Diego, California 92120
United States
Rady Children's Hospital - San Diego
San Diego, California 92123
United States
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado 80218
United States
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
United States
Yale University
New Haven, Connecticut 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware 19803
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida 32207
United States
Nicklaus Children's Hospital
Miami, Florida 33155
United States
Arnold Palmer Hospital for Children
Orlando, Florida 32806
United States
Nemours Children's Hospital
Orlando, Florida 32827
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida 33701
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia 30329
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Saint Jude Midwest Affiliate
Peoria, Illinois 61637
United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois 60190
United States
Riley Hospital for Children
Indianapolis, Indiana 46202
United States
Blank Children's Hospital
Des Moines, Iowa 50309
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Norton Children's Hospital
Louisville, Kentucky 40202
United States
Children's Hospital New Orleans
New Orleans, Louisiana 70118
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Eastern Maine Medical Center
Bangor, Maine 04401
United States
Maine Children's Cancer Program
Scarborough, Maine 04074
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Michigan State University
East Lansing, Michigan 48823
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan 49009
United States
Beacon Kalamazoo
Kalamazoo, Michigan 49048
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan 49677
United States
Corewell Health Children's
Royal Oak, Michigan 48073
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
United States
Munson Medical Center
Traverse City, Michigan 49684
United States
University of Michigan Health - West
Wyoming, Michigan 49519
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
University of Missouri Children's Hospital
Columbia, Missouri 65212
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri 63104
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Mercy Hospital Saint Louis
St Louis, Missouri 63141
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
United States
Las Vegas Urology - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pebble
Henderson, Nevada 89074
United States
Oncology Las Vegas - Henderson
Henderson, Nevada 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pecos
Las Vegas, Nevada 89074
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada 89106
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United States
Las Vegas Urology - Sunset
Las Vegas, Nevada 89113
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89113
United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
United States
Ann M Wierman MD LTD
Las Vegas, Nevada 89128
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada 89148-2405
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89183
United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Saint Mary's Regional Medical Center
Reno, Nevada 89503
United States
Radiation Oncology Associates
Reno, Nevada 89509
United States
Northern Nevada Radiation Oncology
Reno, Nevada 89521
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Morristown Medical Center
Morristown, New Jersey 07960
United States
Saint Peter's University Hospital
New Brunswick, New Jersey 08901
United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08903
United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey 07503
United States
Presbyterian Hospital
Albuquerque, New Mexico 87106
United States
Albany Medical Center
Albany, New York 12208
United States
Maimonides Medical Center
Brooklyn, New York 11219
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York 11040
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
Mount Sinai Hospital
New York, New York 10029
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
United States
Children's Hospital at Montefiore
The Bronx, New York 10467
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
New York Medical College
Valhalla, New York 10595
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Mission Hospital
Asheville, North Carolina 28801
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
East Carolina University
Greenville, North Carolina 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Dayton Children's Hospital
Dayton, Ohio 45404
United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Legacy Emanuel Children's Hospital
Portland, Oregon 97227
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Penn State Children's Hospital
Hershey, Pennsylvania 17033
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee 37916
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee 37203
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas 79106
United States
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
United States
Driscoll Children's Hospital
Corpus Christi, Texas 78411
United States
Medical City Dallas Hospital
Dallas, Texas 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
El Paso Children's Hospital
El Paso, Texas 79905
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
M D Anderson Cancer Center
Houston, Texas 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas 78207
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Primary Children's Hospital
Salt Lake City, Utah 84113
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
Inova Fairfax Hospital
Falls Church, Virginia 22042
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia 23507
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Carilion Children's
Roanoke, Virginia 24014
United States
Overlake Medical Center
Bellevue, Washington 98004
United States
Valley Medical Center
Renton, Washington 98055
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington 98405
United States
Madigan Army Medical Center
Tacoma, Washington 98431
United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington 98902
United States
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United States
The Children's Hospital at Westmead
Westmead, New South Wales 2145
Australia
Royal Children's Hospital
Parkville, Victoria 3052
Australia
Perth Children's Hospital
Perth, Western Australia 6009
Australia
Alberta Children's Hospital
Calgary, Alberta T3B 6A8
Canada
University of Alberta Hospital
Edmonton, Alberta T6G 2B7
Canada
IWK Health Centre
Halifax, Nova Scotia B3K 6R8
Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec H3H 1P3
Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec H3T 1C5
Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec J1H 5N4
Canada
Starship Children's Hospital
Grafton, Auckland 1145
New Zealand
Christchurch Hospital
Christchurch, 8011
New Zealand
HIMA San Pablo Oncologic Hospital
Caguas, 00726
Puerto Rico
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211
Saudi Arabia