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

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches for treating brain tumors that have spread from other cancers: a single high-dose radiation session (called radiosurgery) versus several smaller doses given over multiple visits (called fractionated stereotactic radiotherapy), to find out which approach is more effective and better tolerated for larger brain metastases. **You may be eligible if...** - You are over 18 years old - You have 1 to 10 brain metastases from a solid cancer - Your doctor has determined you need radiation treatment for the brain metastases - Your overall health is good enough (Karnofsky score above 50) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You received whole-brain radiation within 6 weeks before starting this trial, or plan to receive it after - The specific brain tumor to be treated has been irradiated before - Your tumor is located in the brainstem - You cannot have an MRI - You are pregnant or breastfeeding - You have a drug, alcohol, or medication abuse problem - You are already enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Klinik für Strahlentherapie und Radioonkologie Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Klinik für Strahlentherapie Bayreuth

Bayreuth, Bavaria, Germany

Strahlentherapie Coburg

Coburg, Bavaria, Germany

Radio-Log Strahlentherapie Hof

Hof, Bavaria, Germany

Strahlentherapie Süd Kempten

Kempten (Allgäu), Bavaria, Germany

Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)

München, Bavaria, Germany

Klinik und Poliklinik für Strahlentherapie Regensburg

Regensburg, Bavaria, Germany

Klinik für Strahlentherapie und Radioonkologie

Bonn, North Rhine-Westphalia, Germany

Klink und Praxis für Radioonkologie Chemnitz

Chemnitz, Saxony, Germany

Universitätsklinik und Poliklinik für Strahlentherapie Halle

Halle, Saxony-Anhalt, Germany

Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena

Jena, Thuringia, Germany

Klinik für Radioonkologie und Strahlentherapie Charité Berlin

Berlin, Germany

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, Germany

View Full Details on ClinicalTrials.gov

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NCT03697343