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Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

RecruitingPhase 3

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

Who can join

Up to age 50 · All sexes

Full 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.

About the 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.

What is being tested

Sponsor: Children's Oncology Group · Participants: 62 · Started: Apr 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05235165

Locations in the U.S.

AlabamaChildren's Hospital of Alabama, Birmingham
AlaskaProvidence Alaska Medical Center, Anchorage
ArizonaKingman Regional Medical Center, Kingman
Banner Children's at Desert, Mesa
Phoenix Childrens Hospital, Phoenix
Banner University Medical Center - Tucson, Tucson
ArkansasArkansas Children's Hospital, Little Rock
CaliforniaKaiser Permanente-Anaheim, Anaheim
PCR Oncology, Arroyo Grande
Kaiser Permanente-Bellflower, Bellflower
Kaiser Permanente Downey Medical Center, Downey
Kaiser Permanente-Fontana, Fontana
Loma Linda University Medical Center, Loma Linda
Miller Children's and Women's Hospital Long Beach, Long Beach
Cedars-Sinai Medical Center, Los Angeles
Children's Hospital Los Angeles, Los Angeles
Kaiser Permanente Los Angeles Medical Center, Los Angeles
Valley Children's Hospital, Madera
Kaiser Permanente-Oakland, Oakland
Children's Hospital of Orange County, Orange
Lucile Packard Children's Hospital Stanford University, Palo Alto
University of California Davis Comprehensive Cancer Center, Sacramento
Kaiser Permanente-San Diego Zion, San Diego
Rady Children's Hospital - San Diego, San Diego
UCSF Medical Center-Mission Bay, San Francisco
ColoradoChildren's Hospital Colorado, Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver
ConnecticutConnecticut Children's Medical Center, Hartford
Smilow Cancer Center/Yale-New Haven Hospital, New Haven
Yale University, New Haven
DelawareAlfred I duPont Hospital for Children, Wilmington
District of ColumbiaChildren's National Medical Center, Washington D.C.
FloridaGolisano Children's Hospital of Southwest Florida, Fort Myers
Nemours Children's Clinic-Jacksonville, Jacksonville
Nicklaus Children's Hospital, Miami
Arnold Palmer Hospital for Children, Orlando
Nemours Children's Hospital, Orlando
Johns Hopkins All Children's Hospital, St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa
Tampa General Hospital, Tampa
GeorgiaChildren's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta
HawaiiKapiolani Medical Center for Women and Children, Honolulu
IdahoSaint Luke's Cancer Institute - Boise, Boise
IllinoisLurie Children's Hospital-Chicago, Chicago
University of Chicago Comprehensive Cancer Center, Chicago
University of Illinois, Chicago
Loyola University Medical Center, Maywood
OSF Children's Hospital of Illinois, Peoria
Northwestern Medicine Central DuPage Hospital, Winfield
IndianaRiley Hospital for Children, Indianapolis
IowaBlank Children's Hospital, Des Moines
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington
Norton Children's Hospital, Louisville
LouisianaChildren's Hospital New Orleans, New Orleans
Ochsner Medical Center Jefferson, New Orleans
MaineEastern Maine Medical Center, Bangor
Maine Children's Cancer Program, Scarborough
MarylandJohns Hopkins University/Sidney Kimmel Cancer Center, Baltimore
Sinai Hospital of Baltimore, Baltimore
University of Maryland/Greenebaum Cancer Center, Baltimore
Walter Reed National Military Medical Center, Bethesda
MassachusettsDana-Farber Cancer Institute, Boston
Massachusetts General Hospital Cancer Center, Boston
MichiganC S Mott Children's Hospital, Ann Arbor
University of Michigan Rogel Cancer Center, Ann Arbor
Bronson Battle Creek, Battle Creek
Children's Hospital of Michigan, Detroit
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids
Trinity Health Grand Rapids Hospital, Grand Rapids
Beacon Kalamazoo, Kalamazoo
Beacon Kalamazoo Cancer Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
West Michigan Cancer Center, Kalamazoo
Trinity Health Muskegon Hospital, Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital, Niles
Corewell Health Reed City Hospital, Reed City
Corewell Health Children's, Royal Oak
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph
Munson Medical Center, Traverse City
University of Michigan Health - West, Wyoming
MinnesotaChildren's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis
University of Minnesota/Masonic Cancer Center, Minneapolis
Mayo Clinic in Rochester, Rochester
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriUniversity of Missouri Children's Hospital, Columbia
Children's Mercy Hospitals and Clinics, Kansas City
Cardinal Glennon Children's Medical Center, St Louis
Mercy Hospital Saint Louis, St Louis
Washington University School of Medicine, St Louis
NebraskaChildren's Hospital and Medical Center of Omaha, Omaha
University of Nebraska Medical Center, Omaha
NevadaCarson Tahoe Regional Medical Center, Carson City
Comprehensive Cancer Centers of Nevada - Henderson, Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson
Oncology Las Vegas - Henderson, Henderson
Urology Specialists of Nevada - Green Valley, Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas
Hope Cancer Care of Nevada, Las Vegas
Oncology Las Vegas - Tenaya, Las Vegas
OptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
OptumCare Cancer Care at MountainView, Las Vegas
Radiation Oncology Centers of Nevada Central, Las Vegas
Radiation Oncology Centers of Nevada Southeast, Las Vegas
Summerlin Hospital Medical Center, Las Vegas
Sunrise Hospital and Medical Center, Las Vegas
University Medical Center of Southern Nevada, Las Vegas
Urology Specialists of Nevada - Central, Las Vegas
Urology Specialists of Nevada - Northwest, Las Vegas
Urology Specialists of Nevada - Southwest, Las Vegas
Hope Cancer Care of Nevada-Pahrump, Pahrump
Renown Regional Medical Center, Reno
Saint Mary's Regional Medical Center, Reno
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyHackensack University Medical Center, Hackensack
Morristown Medical Center, Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick
Saint Peter's University Hospital, New Brunswick
Saint Joseph's Regional Medical Center, Paterson
New MexicoPresbyterian Hospital, Albuquerque
New YorkAlbany Medical Center, Albany
Maimonides Medical Center, Brooklyn
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York
Memorial Sloan Kettering Cancer Center, New York
Mount Sinai Hospital, New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York
Stony Brook University Medical Center, Stony Brook
State University of New York Upstate Medical University, Syracuse
Children's Hospital at Montefiore, The Bronx
Montefiore Medical Center - Moses Campus, The Bronx
Montefiore Medical Center-Einstein Campus, The Bronx
Montefiore Medical Center-Weiler Hospital, The Bronx
New York Medical College, Valhalla
North CarolinaMission Hospital, Asheville
UNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke University Medical Center, Durham
East Carolina University, Greenville
Wake Forest University Health Sciences, Winston-Salem
North DakotaSanford Broadway Medical Center, Fargo
OhioChildren's Hospital Medical Center of Akron, Akron
Cincinnati Children's Hospital Medical Center, Cincinnati
Cleveland Clinic Foundation, Cleveland
Rainbow Babies and Childrens Hospital, Cleveland
Nationwide Children's Hospital, Columbus
Dayton Children's Hospital, Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonLegacy Emanuel Children's Hospital, Portland
Oregon Health and Science University, Portland
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Geisinger Medical Center, Danville
Penn State Children's Hospital, Hershey
Saint Christopher's Hospital for Children, Philadelphia
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
Rhode IslandRhode Island Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston
Prisma Health Richland Hospital, Columbia
BI-LO Charities Children's Cancer Center, Greenville
South DakotaSanford USD Medical Center - Sioux Falls, Sioux Falls
TennesseeEast Tennessee Childrens Hospital, Knoxville
Saint Jude Children's Research Hospital, Memphis
The Children's Hospital at TriStar Centennial, Nashville
Vanderbilt University/Ingram Cancer Center, Nashville
TexasDell Children's Medical Center of Central Texas, Austin
Driscoll Children's Hospital, Corpus Christi
Medical City Dallas Hospital, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
El Paso Children's Hospital, El Paso
Cook Children's Medical Center, Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston
UT MD Anderson Cancer Center, Houston
Children's Hospital of San Antonio, San Antonio
Methodist Children's Hospital of South Texas, San Antonio
University of Texas Health Science Center at San Antonio, San Antonio
UtahPrimary Children's Hospital, Salt Lake City
VirginiaUniversity of Virginia Cancer Center, Charlottesville
Inova Fairfax Hospital, Falls Church
Children's Hospital of The King's Daughters, Norfolk
VCU Massey Cancer Center at Stony Point, Richmond
VCU Massey Comprehensive Cancer Center, Richmond
Carilion Children's, Roanoke
WashingtonValley Medical Center, Renton
Seattle Children's Hospital, Seattle
Providence Sacred Heart Medical Center and Children's Hospital, Spokane
Madigan Army Medical Center, Tacoma
Mary Bridge Children's Hospital and Health Center, Tacoma
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima
West VirginiaWest Virginia University Healthcare, Morgantown
WisconsinUniversity of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Marshfield Medical Center-Marshfield, Marshfield
Children's Hospital of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.