Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients with Osteosarcoma (clinical phase I/II-Trial)

The OSCAR study is in progress since 2010  and focusses on the radiotherapy of inoperable osteosarcomas and additive radiotherapy in incompletely resected tumors. For pediatric patients, it will be performed as a Phase I / II clinical study at the Heidelberg Ion Beam Therapy Center for Children and Adolescents (KinderHIT).
The OSCAR study is a monocentric, prospective and nonrandomized study.

Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. Standard therapy involves complete resection of the tumor, accompanied by neoadjuvant and adjuvant chemotherapy. However, not all osteosarcomas can be surgically removed. In these cases, radiotherapy may be the only curative therapy approach. It can either "replace" surgery (primary radiotherapy) or be performed on residual tumors after surgery (additive radiotherapy).

Prof. Dr. Dr. Jürgen Debus and his colleagues from the Department of Radiation Oncology at the Heidelberg University Hospital have developed a new type of radiation called heavy ion radiation in recent years. This type of radiation allows a high and targeted effectiveness, while the healthy tissue is largely spared.

The goal of the OSCAR study is determine if heavy ion irradiation of osteosarcomas in children can be performed safely. Therefore, the primary endpoints of the study are feasibility and toxicity.
Local control, the value of FDG-PET as non-invasive response diagnostics, disease-free and overall survival are secondary endpoints.

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