Exploring Regorafenib as Maintenance Therapy After First-line Treatment for Patients Aged 12 and Older With Bone Sarcomas

What this Trial Is About

Researchers are investigating whether regorafenib can help control bone sarcoma after initial treatment. Bone sarcomas are rare cancers of the bone with several types, including osteosarcomas, Ewing sarcomas, and chondrosarcomas. Despite advances, survival rates have plateaued, making new treatment options essential. This phase II study explores if adding regorafenib as maintenance therapy after first-line treatment can delay return or progression of the disease compared to standard surveillance. Participants are randomly assigned to one of two groups. One group receives regorafenib in 28-day cycles 21 days of treatment followed by 7 days off, for up to 12 months. Dosage varies based on age and body surface area. The other group undergoes standard surveillance without additional treatment but with the same follow-up schedule. Close monitoring will evaluate disease control and safety in both groups. During the study, participants will have regular visits for assessments including relapse-free survival over up to 5 years, treatment failure, overall survival, quality of life, safety, and treatment adherence. Clinical tests will check blood counts, organ function, and possible side effects. Patients will be monitored closely to track health status and disease recurrence throughout the study duration.

Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas