A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Who is this study for? Patients with Metastatic Osteosarcoma, Osteosarcoma
What treatments are being studied? Questionnaire Administration+Thoracotomy
Status: Recruiting
Location: See all (232) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alaska
Providence Alaska Medical Center
RECRUITING
Anchorage
Alabama
Children's Hospital of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Kingman Regional Medical Center
RECRUITING
Kingman
Banner Children's at Desert
RECRUITING
Mesa
Phoenix Childrens Hospital
RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
California
Kaiser Permanente-Anaheim
RECRUITING
Anaheim
PCR Oncology
RECRUITING
Arroyo Grande
Kaiser Permanente-Bellflower
RECRUITING
Bellflower
Kaiser Permanente Downey Medical Center
RECRUITING
Downey
Kaiser Permanente-Fontana
RECRUITING
Fontana
Loma Linda University Medical Center
RECRUITING
Loma Linda
Miller Children's and Women's Hospital Long Beach
RECRUITING
Long Beach
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Valley Children's Hospital
RECRUITING
Madera
Kaiser Permanente-Oakland
RECRUITING
Oakland
Children's Hospital of Orange County
RECRUITING
Orange
Lucile Packard Children's Hospital Stanford University
RECRUITING
Palo Alto
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Kaiser Permanente-San Diego Zion
RECRUITING
San Diego
Rady Children's Hospital - San Diego
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
RECRUITING
Denver
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
RECRUITING
New Haven
Yale University
RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
RECRUITING
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
RECRUITING
Fort Myers
University of Florida Health Science Center - Gainesville
RECRUITING
Gainesville
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
Nicklaus Children's Hospital
RECRUITING
Miami
Nemours Children's Hospital
RECRUITING
Orlando
Johns Hopkins All Children's Hospital
RECRUITING
St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING
Tampa
Tampa General Hospital
RECRUITING
Tampa
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING
Atlanta
Hawaii
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Iowa
Blank Children's Hospital
RECRUITING
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Illinois
Lurie Children's Hospital-Chicago
RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
Loyola University Medical Center
RECRUITING
Maywood
Saint Jude Midwest Affiliate
RECRUITING
Peoria
Northwestern Medicine Central DuPage Hospital
RECRUITING
Winfield
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Norton Children's Hospital
RECRUITING
Louisville
Louisiana
Children's Hospital New Orleans
RECRUITING
New Orleans
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
University of Maryland/Greenebaum Cancer Center
RECRUITING
Baltimore
Walter Reed National Military Medical Center
RECRUITING
Bethesda
Maine
Eastern Maine Medical Center
RECRUITING
Bangor
Maine Children's Cancer Program
RECRUITING
Scarborough
Michigan
C S Mott Children's Hospital
RECRUITING
Ann Arbor
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Bronson Battle Creek
RECRUITING
Battle Creek
Children's Hospital of Michigan
RECRUITING
Detroit
Michigan State University
SUSPENDED
East Lansing
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Beacon Kalamazoo
RECRUITING
Kalamazoo
Beacon Kalamazoo Cancer Center
RECRUITING
Kalamazoo
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
Trinity Health Muskegon Hospital
RECRUITING
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITING
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
RECRUITING
Norton Shores
Corewell Health Reed City Hospital
RECRUITING
Reed City
Corewell Health Children's
RECRUITING
Royal Oak
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITING
Saint Joseph
Munson Medical Center
RECRUITING
Traverse City
University of Michigan Health - West
RECRUITING
Wyoming
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
RECRUITING
Minneapolis
University of Minnesota/Masonic Cancer Center
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Missouri
University of Missouri Children's Hospital
RECRUITING
Columbia
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Cardinal Glennon Children's Medical Center
RECRUITING
St Louis
Mercy Hospital Saint Louis
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Mission Hospital
RECRUITING
Asheville
Duke University Medical Center
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Wake Forest University Health Sciences
RECRUITING
Winston-salem
North Dakota
Sanford Broadway Medical Center
RECRUITING
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
Saint Peter's University Hospital
RECRUITING
New Brunswick
Saint Joseph's Regional Medical Center
RECRUITING
Paterson
New Mexico
Presbyterian Hospital
RECRUITING
Albuquerque
Nevada
Carson Tahoe Regional Medical Center
RECRUITING
Carson City
Comprehensive Cancer Centers of Nevada - Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
RECRUITING
Henderson
GenesisCare USA - Henderson
RECRUITING
Henderson
Las Vegas Cancer Center-Henderson
SUSPENDED
Henderson
Las Vegas Urology - Green Valley
RECRUITING
Henderson
Las Vegas Urology - Pebble
RECRUITING
Henderson
OptumCare Cancer Care at Seven Hills
RECRUITING
Henderson
Urology Specialists of Nevada - Green Valley
RECRUITING
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Ann M Wierman MD LTD
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
RECRUITING
Las Vegas
GenesisCare USA - Fort Apache
RECRUITING
Las Vegas
GenesisCare USA - Las Vegas
RECRUITING
Las Vegas
GenesisCare USA - Vegas Tenaya
RECRUITING
Las Vegas
Hope Cancer Care of Nevada
RECRUITING
Las Vegas
Las Vegas Cancer Center-Medical Center
SUSPENDED
Las Vegas
Las Vegas Urology - Cathedral Rock
RECRUITING
Las Vegas
Las Vegas Urology - Pecos
RECRUITING
Las Vegas
Las Vegas Urology - Smoke Ranch
RECRUITING
Las Vegas
Las Vegas Urology - Sunset
RECRUITING
Las Vegas
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
OptumCare Cancer Care at MountainView
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Central
RECRUITING
Las Vegas
Radiation Oncology Centers of Nevada Southeast
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Sunrise Hospital and Medical Center
RECRUITING
Las Vegas
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
Urology Specialists of Nevada - Central
RECRUITING
Las Vegas
Urology Specialists of Nevada - Northwest
RECRUITING
Las Vegas
Urology Specialists of Nevada - Southwest
RECRUITING
Las Vegas
Hope Cancer Care of Nevada-Pahrump
RECRUITING
Pahrump
Northern Nevada Radiation Oncology
SUSPENDED
Reno
Radiation Oncology Associates
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
Saint Mary's Regional Medical Center
RECRUITING
Reno
New York
Albany Medical Center
RECRUITING
Albany
Maimonides Medical Center
RECRUITING
Brooklyn
The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITING
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
Stony Brook University Medical Center
RECRUITING
Stony Brook
State University of New York Upstate Medical University
RECRUITING
Syracuse
Children's Hospital at Montefiore
RECRUITING
The Bronx
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Montefiore Medical Center-Einstein Campus
RECRUITING
The Bronx
Montefiore Medical Center-Weiler Hospital
RECRUITING
The Bronx
New York Medical College
RECRUITING
Valhalla
Westchester Medical Center
RECRUITING
Valhalla
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Rainbow Babies and Childrens Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
RECRUITING
Columbus
Dayton Children's Hospital
RECRUITING
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Geisinger Medical Center
RECRUITING
Danville
Penn State Children's Hospital
RECRUITING
Hershey
Saint Christopher's Hospital for Children
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health Richland Hospital
RECRUITING
Columbia
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
RECRUITING
Knoxville
Saint Jude Children's Research Hospital
RECRUITING
Memphis
The Children's Hospital at TriStar Centennial
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
Texas Tech University Health Sciences Center-Amarillo
RECRUITING
Amarillo
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
Driscoll Children's Hospital
RECRUITING
Corpus Christi
Medical City Dallas Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
El Paso Children's Hospital
RECRUITING
El Paso
Cook Children's Medical Center
RECRUITING
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
Children's Hospital of San Antonio
RECRUITING
San Antonio
Methodist Children's Hospital of South Texas
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Falls Church
Children's Hospital of The King's Daughters
RECRUITING
Norfolk
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Carilion Children's
RECRUITING
Roanoke
Vermont
University of Vermont and State Agricultural College
ACTIVE_NOT_RECRUITING
Burlington
Washington
Overlake Medical Center
SUSPENDED
Bellevue
Valley Medical Center
RECRUITING
Renton
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Madigan Army Medical Center
RECRUITING
Tacoma
Mary Bridge Children's Hospital and Health Center
RECRUITING
Tacoma
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
RECRUITING
Yakima
Wisconsin
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Marshfield Medical Center-Marshfield
SUSPENDED
Marshfield
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
West Virginia
West Virginia University Healthcare
RECRUITING
Morgantown
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Parkville
Perth Children's Hospital
SUSPENDED
Perth
The Children's Hospital at Westmead
RECRUITING
Westmead
Canada
Alberta Children's Hospital
RECRUITING
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
IWK Health Centre
RECRUITING
Halifax
Centre Hospitalier Universitaire Sainte-Justine
RECRUITING
Montreal
The Montreal Children's Hospital of the MUHC
RECRUITING
Montreal
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
RECRUITING
Sherbrooke
New Zealand
Christchurch Hospital
RECRUITING
Christchurch
Starship Children's Hospital
RECRUITING
Grafton
Puerto Rico
HIMA San Pablo Oncologic Hospital
ACTIVE_NOT_RECRUITING
Caguas
Saudi Arabia
King Faisal Specialist Hospital and Research Centre
SUSPENDED
Riyadh
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 250
Treatments
Experimental: Arm A (thoracotomy)
Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
Experimental: Arm B (thoracoscopy)
Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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