Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Sponsored by Children's Oncology Group
About this study
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.
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 …
Where this study is enrolling (202)
- I'm interested
Children's Hospital of Alabama
Birmingham, Alabama
- I'm interested
Providence Alaska Medical Center
Anchorage, Alaska
- Call 602-933-1000
Phoenix Childrens Hospital
Phoenix, Arizona
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Banner University Medical Center - Tucson
Tucson, Arizona
- Call 480-412-3100
Banner Children's at Desert
Mesa, Arizona
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Show all 202 locations
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Kingman Regional Medical Center
Kingman, Arizona
- Call 501-364-7373
Arkansas Children's Hospital
Little Rock, Arkansas
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, California
- I'm interested
Kaiser Permanente-Anaheim
Anaheim, California
- I'm interested
Kaiser Permanente-Bellflower
Bellflower, California
- I'm interested
UCSF Medical Center-Mission Bay
San Francisco, California
- Call 858-966-5934
Rady Children's Hospital - San Diego
San Diego, California
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Kaiser Permanente-San Diego Zion
San Diego, California
- I'm interested
Kaiser Permanente-Oakland
Oakland, California
- I'm interested
Kaiser Permanente-Fontana
Fontana, California
- Call 562-933-5600
Miller Children's and Women's Hospital Long Beach
Long Beach, California
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- Call 626-564-3455
Kaiser Permanente Downey Medical Center
Downey, California
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Cedars-Sinai Medical Center
Los Angeles, California
- I'm interested
PCR Oncology
Arroyo Grande, California
- Call 916-734-3089
University of California Davis Comprehensive Cancer Center
Sacramento, California
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- Call 323-361-4110
Children's Hospital Los Angeles
Los Angeles, California
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- Call 909-558-4050
Loma Linda University Medical Center
Loma Linda, California
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Children's Hospital of Orange County
Orange, California
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Lucile Packard Children's Hospital Stanford University
Palo Alto, California
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Valley Children's Hospital
Madera, California
- I'm interested
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado
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Children's Hospital Colorado
Aurora, Colorado
- Call 860-545-9981
Connecticut Children's Medical Center
Hartford, Connecticut
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Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut
- I'm interested
Yale University
New Haven, Connecticut
- I'm interested
Alfred I duPont Hospital for Children
Wilmington, Delaware
- I'm interested
Children's National Medical Center
Washington D.C., District of Columbia
- I'm interested
Johns Hopkins All Children's Hospital
St. Petersburg, Florida
- I'm interested
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida
- I'm interested
Arnold Palmer Hospital for Children
Orlando, Florida
- I'm interested
Tampa General Hospital
Tampa, Florida
- I'm interested
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida
- Call 888-624-2778
Nicklaus Children's Hospital
Miami, Florida
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Nemours Children's Hospital
Orlando, Florida
- I'm interested
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida
- I'm interested
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia
- Call 808-983-6090
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii
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- I'm interested
Saint Luke's Cancer Institute - Boise
Boise, Idaho
- I'm interested
OSF Children's Hospital of Illinois
Peoria, Illinois
- I'm interested
University of Chicago Comprehensive Cancer Center
Chicago, Illinois
- I'm interested
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois
- Call 312-355-3046
University of Illinois
Chicago, Illinois
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Lurie Children's Hospital-Chicago
Chicago, Illinois
- Call 708-226-4357
Loyola University Medical Center
Maywood, Illinois
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- Call 800-248-1199
Riley Hospital for Children
Indianapolis, Indiana
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- Call 800-237-1225
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa
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- I'm interested
Blank Children's Hospital
Des Moines, Iowa
- I'm interested
Norton Children's Hospital
Louisville, Kentucky
- Call 859-257-3379
University of Kentucky/Markey Cancer Center
Lexington, Kentucky
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Ochsner Medical Center Jefferson
New Orleans, Louisiana
- Call 504-894-5377
Children's Hospital New Orleans
New Orleans, Louisiana
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- Call 207-973-4274
Eastern Maine Medical Center
Bangor, Maine
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- I'm interested
Maine Children's Cancer Program
Scarborough, Maine
- Call 410-601-9083
Sinai Hospital of Baltimore
Baltimore, Maryland
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- I'm interested
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland
- Call 800-888-8823
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland
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- Call 301-319-2100
Walter Reed National Military Medical Center
Bethesda, Maryland
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- Call 877-726-5130
Massachusetts General Hospital Cancer Center
Boston, Massachusetts
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- Call 877-442-3324
Dana-Farber Cancer Institute
Boston, Massachusetts
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- Call 616-391-1230
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan
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- Call 574-647-7370
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan
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- Call 574-647-7370
Beacon Kalamazoo
Kalamazoo, Michigan
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Bronson Battle Creek
Battle Creek, Michigan
- I'm interested
Bronson Methodist Hospital
Kalamazoo, Michigan
- Call 800-865-1125
C S Mott Children's Hospital
Ann Arbor, Michigan
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- I'm interested
Children's Hospital of Michigan
Detroit, Michigan
- Call 248-551-7695
Corewell Health Children's
Royal Oak, Michigan
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- I'm interested
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
- I'm interested
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan
- I'm interested
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan
- I'm interested
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan
- I'm interested
Corewell Health Reed City Hospital
Reed City, Michigan
- I'm interested
Munson Medical Center
Traverse City, Michigan
- I'm interested
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan
- I'm interested
Trinity Health Muskegon Hospital
Muskegon, Michigan
- I'm interested
University of Michigan Health - West
Wyoming, Michigan
- I'm interested
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan
- I'm interested
West Michigan Cancer Center
Kalamazoo, Michigan
- Call 855-776-0015
Mayo Clinic in Rochester
Rochester, Minnesota
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- Call 612-624-2620
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota
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- I'm interested
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota
- Call 601-815-6700
University of Mississippi Medical Center
Jackson, Mississippi
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- I'm interested
University of Missouri Children's Hospital
Columbia, Missouri
- Call 314-268-4000
Cardinal Glennon Children's Medical Center
St Louis, Missouri
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- I'm interested
Washington University School of Medicine
St Louis, Missouri
- I'm interested
Children's Mercy Hospitals and Clinics
Kansas City, Missouri
- Call 314-251-7066
Mercy Hospital Saint Louis
St Louis, Missouri
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University of Nebraska Medical Center
Omaha, Nebraska
- Call 402-955-3949
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska
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- I'm interested
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada
- I'm interested
Oncology Las Vegas - Henderson
Henderson, Nevada
- I'm interested
Oncology Las Vegas - Tenaya
Las Vegas, Nevada
- I'm interested
OptumCare Cancer Care at Charleston
Las Vegas, Nevada
- I'm interested
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada
- I'm interested
OptumCare Cancer Care at MountainView
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada
- I'm interested
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada
- I'm interested
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada
- I'm interested
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada
- I'm interested
Renown Regional Medical Center
Reno, Nevada
- I'm interested
Saint Mary's Regional Medical Center
Reno, Nevada
- I'm interested
Summerlin Hospital Medical Center
Las Vegas, Nevada
- I'm interested
Sunrise Hospital and Medical Center
Las Vegas, Nevada
- I'm interested
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
- I'm interested
University Medical Center of Southern Nevada
Las Vegas, Nevada
- I'm interested
Carson Tahoe Regional Medical Center
Carson City, Nevada
- I'm interested
Urology Specialists of Nevada - Central
Las Vegas, Nevada
- I'm interested
Urology Specialists of Nevada - Green Valley
Henderson, Nevada
- I'm interested
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada
- I'm interested
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada
- I'm interested
Hope Cancer Care of Nevada
Las Vegas, Nevada
- I'm interested
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada
- I'm interested
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire
- Call 732-235-8675
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey
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- I'm interested
Saint Joseph's Regional Medical Center
Paterson, New Jersey
- I'm interested
Saint Peter's University Hospital
New Brunswick, New Jersey
- Call 973-971-5900
Morristown Medical Center
Morristown, New Jersey
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- Call 551-996-2897
Hackensack University Medical Center
Hackensack, New Jersey
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- I'm interested
Presbyterian Hospital
Albuquerque, New Mexico
- I'm interested
Montefiore Medical Center-Weiler Hospital
The Bronx, New York
- I'm interested
Montefiore Medical Center-Einstein Campus
The Bronx, New York
- Call 718-470-3460
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York
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- I'm interested
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York
- I'm interested
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York
- Call 914-594-3794
New York Medical College
Valhalla, New York
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- Call 518-262-5513
Albany Medical Center
Albany, New York
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- I'm interested
Mount Sinai Hospital
New York, New York
- I'm interested
Montefiore Medical Center - Moses Campus
The Bronx, New York
- Call 718-765-2500
Maimonides Medical Center
Brooklyn, New York
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- Call 212-639-7592
Memorial Sloan Kettering Cancer Center
New York, New York
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- I'm interested
Children's Hospital at Montefiore
The Bronx, New York
- Call 315-464-5476
State University of New York Upstate Medical University
Syracuse, New York
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- Call 800-862-2215
Stony Brook University Medical Center
Stony Brook, New York
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- I'm interested
Mission Hospital
Asheville, North Carolina
- Call 336-713-6771
Wake Forest University Health Sciences
Winston-Salem, North Carolina
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- Call 888-275-3853
Duke University Medical Center
Durham, North Carolina
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- I'm interested
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
- I'm interested
East Carolina University
Greenville, North Carolina
- I'm interested
Sanford Broadway Medical Center
Fargo, North Dakota
- I'm interested
Nationwide Children's Hospital
Columbus, Ohio
- I'm interested
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio
- Call 330-543-3193
Children's Hospital Medical Center of Akron
Akron, Ohio
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- Call 216-844-5437
Rainbow Babies and Childrens Hospital
Cleveland, Ohio
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- Call 800-228-4055
Dayton Children's Hospital
Dayton, Ohio
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- I'm interested
Cleveland Clinic Foundation
Cleveland, Ohio
- I'm interested
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
- I'm interested
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
- I'm interested
Oregon Health and Science University
Portland, Oregon
- Call 503-413-2560
Legacy Emanuel Children's Hospital
Portland, Oregon
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- I'm interested
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania
- I'm interested
Geisinger Medical Center
Danville, Pennsylvania
- I'm interested
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania
- Call 717-531-6012
Penn State Children's Hospital
Hershey, Pennsylvania
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- I'm interested
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania
- Call 401-444-1488
Rhode Island Hospital
Providence, Rhode Island
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Prisma Health Richland Hospital
Columbia, South Carolina
- I'm interested
BI-LO Charities Children's Cancer Center
Greenville, South Carolina
- I'm interested
Medical University of South Carolina
Charleston, South Carolina
- I'm interested
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
- Call 800-811-8480
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee
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- Call 865-541-8266
East Tennessee Childrens Hospital
Knoxville, Tennessee
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Saint Jude Children's Research Hospital
Memphis, Tennessee
- Call 615-342-1919
The Children's Hospital at TriStar Centennial
Nashville, Tennessee
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- I'm interested
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
- I'm interested
Cook Children's Medical Center
Fort Worth, Texas
- Call 972-566-5588
Medical City Dallas Hospital
Dallas, Texas
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Dell Children's Medical Center of Central Texas
Austin, Texas
- I'm interested
Driscoll Children's Hospital
Corpus Christi, Texas
- I'm interested
Methodist Children's Hospital of South Texas
San Antonio, Texas
- I'm interested
University of Texas Health Science Center at San Antonio
San Antonio, Texas
- I'm interested
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas
- I'm interested
El Paso Children's Hospital
El Paso, Texas
- I'm interested
UT MD Anderson Cancer Center
Houston, Texas
- I'm interested
Children's Hospital of San Antonio
San Antonio, Texas
- Call 801-585-5270
Primary Children's Hospital
Salt Lake City, Utah
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- I'm interested
Inova Fairfax Hospital
Falls Church, Virginia
- I'm interested
Carilion Children's
Roanoke, Virginia
- I'm interested
Children's Hospital of The King's Daughters
Norfolk, Virginia
- I'm interested
VCU Massey Cancer Center at Stony Point
Richmond, Virginia
- I'm interested
VCU Massey Comprehensive Cancer Center
Richmond, Virginia
- I'm interested
University of Virginia Cancer Center
Charlottesville, Virginia
- I'm interested
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington
- I'm interested
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington
- I'm interested
Madigan Army Medical Center
Tacoma, Washington
- I'm interested
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington
- Call 866-987-2000
Seattle Children's Hospital
Seattle, Washington
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Valley Medical Center
Renton, Washington
- I'm interested
West Virginia University Healthcare
Morgantown, West Virginia
- I'm interested
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin
- I'm interested
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin
- I'm interested
Children's Hospital of Wisconsin
Milwaukee, Wisconsin
- I'm interested
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin
Who can participate
Inclusion criteria
- ✓Patients must be \< 50 years at the time of enrollment.
- ✓Patients must have =\< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \>= 3 mm and all of which must be =\< 3 cm size.
- ✓Note: Patient must have eligibility confirmed by rapid central imaging review.
- ✓Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
- ✓Patients must have a histological diagnosis of osteosarcoma.
- ✓Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
- ✓Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
- ✓Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
- ✓Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
Exclusion criteria
- ✕Patients with unresectable primary tumor.
- ✕Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
- ✕Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
- ✕Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
- ✕Patients with evidence of extrapulmonary metastatic disease.
- ✕Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
- ✕All patients and/or their parents or legal guardians must sign a written informed consent.
- ✕All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.