Osteosarcoma Clinical Trial
Official title:
Phase I/II Therapy Trial to Determine the Safety and Efficacy of Heavy Ion Radiotherapy in Patients With Osteosarcoma
The primary objectives of this trial are the determination of feasibility and toxicity of Heavy Ion Radiotherapy (C12) in patients with non-resectable osteosarcoma. Secondary endpoints are tumor response, disease free survival and overall survival. The aim is to improve outcome for patients with non-resectable osteosarcoma.
Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For
effective treatment, local control of the tumor is absolutely critical, because the chances
of long term survival are <10% and might effectively approach zero if a complete surgical
resection of the tumor is not possible. Up to date there is no curative treatment protocol
for patients with non-resectable osteosarcomas, who are excluded from current osteosarcoma
trials , e.g. EURAMOS1. Local photon radiotherapy has previously been used in small series
and in an uncontrolled, highly individualized fashion, which, however, documented that high
dose radiotherapy can, in principle, be used to achieve local control. Generally the
radiation dose that is necessary for a curative approach can hardly be achieved with
conventional photon radiotherapy in patients with non-resectable tumors that are usually
located near radiosensitive critical organs such as the brain, the spine or the pelvis. In
these cases Heavy Ion Radiotherapy (HIT) may offer a promising new alternative. Moreover,
compared with photons, heavy ion particles provide a higher physical selectivity because of
their finite depth coverage in tissue. They achieve a higher relative biological
effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone
and soft tissue sarcomas have already shown favorable results.
Methods/Design: This is a monocenter, non-randomized study for patients older than 6 years of
age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent
(GyE). Weekly fractionation of 6 x 3 Gy E is used. HIT will be administered exclusively at
the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of
non-resectable osteosarcoma before and after HIT will be investigated prospectively. Systemic
disease before and after HIT is targeted by standard chemotherapy protocols and is not part
of this trial.
The primary objectives of this trial are the determination of feasibility and toxicity of
HIT. Secondary endpoints are tumor response, disease free survival and overall survival. The
aim is to improve outcome for patients with non-resectable osteosarcoma.
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