RECRUITING Phase 3 ClinicalTrials.gov

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Sponsor: Children's Oncology Group • ClinicalTrials.gov ID: NCT05235165

Registry updated: 2026-08-25

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Description

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.

Interventions

Biospecimen Collection (Procedure)
Undergo collection of tissue and blood
Computed Tomography (Procedure)
Undergo CT
Questionnaire Administration (Other)
Ancillary studies
Thoracoscopy (Procedure)
Undergo video-assisted thoracoscopic surgery or VATS
Thoracotomy (Procedure)
Undergo open thoracic surgery

Eligibility criteria

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.

Conditions

Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma Osteosarcoma

Locations

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

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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