Home
Clinical Trials
NCT05235165

Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2031-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

III. To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference 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 prospectively compare between treatment arms the relationship between surgical approach and patient-reported outcomes (PROs), specifically patient functional impairment of the upper extremities, pain intensity, and health-related quality of life (HRQoL).

VII. To generate well-characterized, clinically-annotated, distributable models of metastatic osteosarcoma.

VIII. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Malignant Neoplasm in the Lung Metastatic Osteosarcoma Osteosarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A (thoracotomy)

Patients undergo open thoracic surgery (thoracotomy). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of tissue and blood

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Thoracotomy

Intervention Type PROCEDURE

Undergo open thoracic surgery

Arm B (thoracoscopy)

Patients undergo thoracoscopy (video-assisted thoracoscopic surgery or VATS). Patients undergo CT throughout the trial. Patients may also undergo collection of tissue on study and blood throughout the trial.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of tissue and blood

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Thoracoscopy

Intervention Type PROCEDURE

Undergo video-assisted thoracoscopic surgery or VATS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo collection of tissue and blood

Intervention Type PROCEDURE

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Thoracoscopy

Undergo video-assisted thoracoscopic surgery or VATS

Intervention Type PROCEDURE

Thoracotomy

Undergo open thoracic surgery

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography Pleuroscopy incision of Chest Wall Incision of Thorax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John J Doski

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status RECRUITING

Kingman Regional Medical Center

Kingman, Arizona, United States

Site Status RECRUITING

Banner Children's at Desert

Mesa, Arizona, United States

Site Status RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status RECRUITING

PCR Oncology

Arroyo Grande, California, United States

Site Status RECRUITING

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, United States

Site Status RECRUITING

Kaiser Permanente-Fontana

Fontana, California, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Valley Children's Hospital

Madera, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

Children's Hospital of Orange County

Orange, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Site Status RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Site Status RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Site Status RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

Tampa General Hospital

Tampa, Florida, United States

Site Status RECRUITING

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Site Status RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

Blank Children's Hospital

Des Moines, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status RECRUITING

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status RECRUITING

Maine Children's Cancer Program

Scarborough, Maine, United States

Site Status RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status RECRUITING

Michigan State University

East Lansing, Michigan, United States

Site Status SUSPENDED

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Beacon Kalamazoo

Kalamazoo, Michigan, United States

Site Status RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status RECRUITING

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Site Status RECRUITING

Corewell Health Children's

Royal Oak, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

University of Missouri Children's Hospital

Columbia, Missouri, United States

Site Status RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status RECRUITING

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Site Status RECRUITING

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status RECRUITING

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Site Status RECRUITING

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status SUSPENDED

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status RECRUITING

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status RECRUITING

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Site Status RECRUITING

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Site Status RECRUITING

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

Site Status RECRUITING