RecruitingPhase 3NCT05235165

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

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

Sponsor

Children's Oncology Group

Enrollment

62 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma

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

Max Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for removing lung tumors in young patients with osteosarcoma (a type of bone cancer that has spread to the lungs): open chest surgery (thoracotomy) versus minimally invasive keyhole surgery (thoracoscopy). Researchers want to know whether the less invasive approach is just as effective. **You may be eligible if...** - You are under 50 years old with a diagnosis of osteosarcoma - You have 4 or fewer lung nodules suspicious for cancer spread - The lung nodules can be surgically removed - You have had, or are receiving, standard chemotherapy for osteosarcoma **You may NOT be eligible if...** - Your primary bone tumor cannot be removed surgically - You have cancer spread beyond the lungs (e.g., bones, brain, chest wall) - You have already had lung surgery for metastases - Your lung lesions require removal of an entire lobe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of tissue and blood

PROCEDUREComputed Tomography

Undergo CT

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREThoracoscopy

Undergo video-assisted thoracoscopic surgery or VATS

PROCEDUREThoracotomy

Undergo open thoracic surgery

Locations(232)

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

Saint Jude Midwest Affiliate

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

OptumCare Cancer Care at Seven Hills

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