RecruitingPhase 3NCT03697343
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)
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
382 participants
Start Date
May 18, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- Age \> 18 years, no upper age limit
- Karnofsky Performance Score \> 50 points
- Expected Survival \> 3 months
- cerebral metastases of metastatic solid cancer
- Indication for local radiotherapy
- Patients must be able to understand the protocol and provide informed consent
Exclusion Criteria10
- 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
Interventions
RADIATIONRadiosurgery
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
RADIATIONFractionated stereotactic radiotherapy
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03697343