Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Launched by CHILDREN'S ONCOLOGY GROUP · Jan 31, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing two different surgical methods to treat patients with osteosarcoma, a type of bone cancer that has spread to the lungs. The two methods are open thoracic surgery, which involves a larger incision to access the chest, and thoracoscopic surgery, which uses small incisions and a camera to guide the surgery. The goal of the study is to find out which approach is more effective for removing lung cancer nodules caused by osteosarcoma.
To participate in this trial, patients need to be under 50 years old and have a specific number and size of lung nodules that can be surgically removed. They must also have a confirmed diagnosis of osteosarcoma and must have completed or be undergoing standard treatments for the disease. Participants will undergo one of the two surgical procedures and will be monitored for outcomes related to their cancer treatment. It’s important for potential participants and their families to understand the eligibility criteria and to discuss any questions with their healthcare team before considering enrollment.
Gender
ALL
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 Children's Oncology Group
The Children's Oncology Group (COG) is a leading national organization dedicated to improving the care and outcomes of children with cancer through collaborative research and clinical trials. Comprising a network of pediatric oncology experts, COG focuses on developing innovative treatment protocols, advancing scientific knowledge, and enhancing the quality of life for young patients. By fostering interdisciplinary collaboration and utilizing a comprehensive approach to childhood cancer, COG aims to translate research findings into effective therapies, ultimately striving for a cure for all children diagnosed with cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Brooklyn, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Saint Louis, Missouri, United States
Detroit, Michigan, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Kalamazoo, Michigan, United States
Maywood, Illinois, United States
Boston, Massachusetts, United States
Riyadh, , Saudi Arabia
Loma Linda, California, United States
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Bangor, Maine, United States
Anchorage, Alaska, United States
Hackensack, New Jersey, United States
Edmonton, Alberta, Canada
Peoria, Illinois, United States
Oklahoma City, Oklahoma, United States
Parkville, Victoria, Australia
Orange, California, United States
Scarborough, Maine, United States
Akron, Ohio, United States
Norfolk, Virginia, United States
New York, New York, United States
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Little Rock, Arkansas, United States
Des Moines, Iowa, United States
Halifax, Nova Scotia, Canada
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
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Hershey, Pennsylvania, United States
Charlottesville, Virginia, United States
Houston, Texas, United States
Las Vegas, Nevada, United States
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San Antonio, Texas, United States
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Danville, Pennsylvania, United States
Tucson, Arizona, United States
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Chicago, Illinois, United States
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Bethesda, Maryland, United States
Minneapolis, Minnesota, United States
Omaha, Nebraska, United States
Bronx, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
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Fargo, North Dakota, United States
Nashville, Tennessee, United States
Burlington, Vermont, United States
Birmingham, Alabama, United States
Hartford, Connecticut, United States
Lexington, Kentucky, United States
Bronx, New York, United States
Allentown, Pennsylvania, United States
Morgantown, West Virginia, United States
Falls Church, Virginia, United States
Washington, District Of Columbia, United States
Wyoming, Michigan, United States
Honolulu, Hawaii, United States
Portland, Oregon, United States
Grand Rapids, Michigan, United States
Portland, Oregon, United States
Cleveland, Ohio, United States
Phoenix, Arizona, United States
Oakland, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Wilmington, Delaware, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
East Lansing, Michigan, United States
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Albany, New York, United States
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Dayton, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
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Fort Worth, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
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Grafton, Auckland, New Zealand
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Downey, California, United States
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Bronx, New York, United States
Asheville, North Carolina, United States
Toledo, Ohio, United States
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Greenville, South Carolina, United States
Memphis, Tennessee, United States
Roanoke, Virginia, United States
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Marshfield, Wisconsin, United States
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Westmead, New South Wales, Australia
Montreal, Quebec, Canada
Reno, Nevada, United States
Tampa, Florida, United States
Bronx, New York, United States
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Los Angeles, California, United States
Battle Creek, Michigan, United States
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Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Saint Joseph, Michigan, United States
Reno, Nevada, United States
Greenville, North Carolina, United States
Mesa, Arizona, United States
Boise, Idaho, United States
Royal Oak, Michigan, United States
Amarillo, Texas, United States
Sherbrooke, Quebec, Canada
Saint Joseph, Michigan, United States
Las Vegas, Nevada, United States
San Antonio, Texas, United States
Perth, Western Australia, Australia
Niles, Michigan, United States
Winfield, Illinois, United States
Arroyo Grande, California, United States
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Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Norton Shores, Michigan, United States
Carson City, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
El Paso, Texas, United States
Caguas, , Puerto Rico
Columbia, Missouri, United States
Oklahoma City, Oklahoma, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Henderson, Nevada, United States
Pahrump, Nevada, United States
New Haven, Connecticut, United States
Reno, Nevada, United States
Kingman, Arizona, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Kalamazoo, Michigan, United States
Los Angeles, California, United States
East Lansing, Michigan, United States
Perth, Western Australia, Australia
Columbus, Ohio, United States
Lebanon, New Hampshire, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
Grand Rapids, Michigan, United States
Saint Joseph, Michigan, United States
Madison, Wisconsin, United States
Grand Rapids, Michigan, United States
Royal Oak, Michigan, United States
Atlanta, Georgia, United States
Kalamazoo, Michigan, United States
Patients applied
Trial Officials
John J Doski
Principal Investigator
Children's Oncology Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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