Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)

Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)

This is a prospective, multicenter randomized trial comparing local control and side effects after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will be stratified by metastasis volume and histology.

Inclusion Criteria:

• Age > 18 years, no upper age limit
• Karnofsky Performance Score > 50 points
• Expected Survival > 3 months
• 1-10 cerebral metastases of metastatic solid cancer
• Indication for local radiotherapy
• Patients must be able to understand the protocol and provide informed consent

Exclusion Criteria:

• Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy
• Prior irradiation of the cerebral metastasis that is to be treated in the study
• Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study
• Metastasis in the brainstem
• Contraindication for cerebral MRI
• Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence
• Pregnant or lactating women
• Abuse of illicit drugs, alcohol or medication
• Patient not able or willing to behave according to protocol
• Participation in another clinical trial