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Treatment Patterns and Survival Outcomes in High-Grade Osteosarcoma: A Multicenter Retrospective Study
Sponsor: MedPacto, Inc.
Summary
This is a multicenter, medical-record-based, retrospective observational study of approximately 400 patients with high-grade osteosarcoma treated at four sites in the Republic of Korea. The study describes treatment patterns and survival outcomes (event-free survival \[EFS\], progression-free survival \[PFS\], and overall survival \[OS\]) in patients who completed or discontinued first-line treatment for high-grade osteosarcoma, irrespective of complete remission status. The primary objective is to retrospectively estimate the 12-month EFS rate, calculated from the date of diagnosis, in the full cohort of high-grade osteosarcoma patients. Key secondary objectives evaluate EFS and OS from the date of confirmed complete remission/no evidence of disease (CR/NED) in the subset of clinically high-risk patients who achieve CR/NED, in order to establish a historical reference data supporting the design and interpretation of a future prospective clinical trial of vactosertib as maintenance therapy.
Official title: A Multicenter Medical-Record-Based Retrospective Study of Treatment Patterns and Survival Outcomes in Patients With High-Grade Osteosarcoma
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-07-13
Completion Date
2027-12-31
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Locations (4)
National Cancer Center
Goyang-si, South Korea
Asan Medical Center
Seoul, South Korea
Korea Cancer Center Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea