Overview
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)
Description
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.
Eligibility
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