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NCT05235165PHASE3Recruiting

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Children's Oncology Group

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

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.

Interventions

PROCEDURE

Biospecimen Collection

PROCEDURE

Computed Tomography

OTHER

Questionnaire Administration

PROCEDURE

Thoracoscopy

PROCEDURE

Thoracotomy

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Conditions

Metastatic Malignant Neoplasm in the LungMetastatic OsteosarcomaOsteosarcoma

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