Status:
RECRUITING
Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Cerebral Metastases of Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)
Detailed 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 RT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT03697343
Start Date
May 18 2021
End Date
May 1 2026
Last Update
December 13 2022
Active Locations (13)
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1
Klinik für Strahlentherapie und Radioonkologie Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70174
2
Klinik für Strahlentherapie Bayreuth
Bayreuth, Bavaria, Germany, 95445
3
Strahlentherapie Coburg
Coburg, Bavaria, Germany, 96450
4
Radio-Log Strahlentherapie Hof
Hof, Bavaria, Germany, 95032