About this trial
This study looks at how well cabozantinib works when added to standard chemotherapy for patients with newly diagnosed osteosarcoma. The goal is to see if this combination is safe and if it helps patients do better than just chemotherapy alone. Cabozantinib is a medicine that may help stop tumor growth by blocking signals that allow cancer cells to grow and form new blood vessels. The standard chemotherapy includes medicines like methotrexate, doxorubicin, and cisplatin.
The trial's ID number is NCT05691478. It is a Phase 2/3 study, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated, and it aims to include about 1,122 participants.
Who can join
This trial is open to men and women under 40 years old. Participants must have a confirmed diagnosis of high-grade osteosarcoma and meet certain health criteria. Those with both localized and metastatic disease are eligible. The trial team will confirm if you qualify to join.
Conditions
High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed in one of several groups by chance. Some will receive standard chemotherapy, while others will receive chemotherapy along with cabozantinib. The study includes different phases for both standard risk and high-risk patients, with various treatment plans involving cycles of chemotherapy and evaluations throughout the trial.
Where
This trial is running at 177 locations in the United States. All of them are currently recruiting.
AdventHealth Orlando
Orlando, Florida
Albany Medical Center
Albany, New York
Alfred I duPont Hospital for Children
Wilmington, Delaware
Allegiance Health
Jackson, Michigan
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Arkansas Children's Hospital
Little Rock, Arkansas
Arnold Palmer Hospital for Children
Orlando, Florida
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina
The first 8 of 177 sites are listed here. The registry record has the full list.