Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
NCT ID: NCT03697343
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
382 participants
INTERVENTIONAL
2021-05-18
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005
Radiosurgery
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin
Fractionated stereotactic radiotherapy
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Interventions
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Radiosurgery
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Fractionated stereotactic radiotherapy
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Rainer Fietkau, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Erlangen, Strahlenklinik
Florian Putz, PD Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Erlangen, Strahlenklinik
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Marc Münter, Prof. Dr.
Role: primary
Ludwig Keilholz, Prof. Dr.
Role: primary
Gerhard Grabenbauer, Prof. Dr.
Role: primary
Christoph Straube, PD Dr.
Role: primary
Sterzing, Prof. Dr.
Role: primary
Denise Bernhardt, PD Dr.
Role: primary
Oliver Kölbl, Prof. Dr.
Role: primary
Christopher Schmeel, PD Dr.
Role: primary
Gunther Klautke, PD Dr. med.
Role: primary
Christian Dietzel, Dr. med.
Role: primary
Andrea Wittig, Prof. Dr.
Role: primary
Felix Ehret, Dr. med.
Role: primary
Rainer Fietkau, Prof.
Role: primary
Other Identifiers
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FSRT-Trial
Identifier Type: -
Identifier Source: org_study_id