Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

Last updated: December 9, 2022
Sponsor: University of Erlangen-Nürnberg Medical School
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT03697343
FSRT-Trial
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Whole Brain radiotherapy no longer than 6 weeks before the start of stereotacticradiotherapy 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 treatedin 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-enhancedT1 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

Study Design

Total Participants: 382
Study Start date:
May 18, 2021
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Klinik für Strahlentherapie und Radioonkologie Stuttgart

    Stuttgart, Baden-Württemberg 70174
    Germany

    Active - Recruiting

  • Klinik für Strahlentherapie Bayreuth

    Bayreuth, Bayern 95445
    Germany

    Active - Recruiting

  • Strahlentherapie Coburg

    Coburg, Bayern 96450
    Germany

    Active - Recruiting

  • Radio-Log Strahlentherapie Hof

    Hof, Bayern 95032
    Germany

    Active - Recruiting

  • Strahlentherapie Süd Kempten

    Kempten, Bayern 87439
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)

    München, Bayern 81675
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für Strahlentherapie Regensburg

    Regensburg, Bayern 93053
    Germany

    Active - Recruiting

  • Klinik für Strahlentherapie und Radioonkologie

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Active - Recruiting

  • Klink und Praxis für Radioonkologie Chemnitz

    Chemnitz, Sachsen 09113
    Germany

    Active - Recruiting

  • Universitätsklinik und Poliklinik für Strahlentherapie Halle

    Halle, Sachsen-Anhalt 06120
    Germany

    Active - Recruiting

  • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena

    Jena, Thüringen 07745
    Germany

    Active - Recruiting

  • Klinik für Radioonkologie und Strahlentherapie Charité Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Erlangen, Universitätsklinikum Strahlenklinik

    Erlangen, 91054
    Germany

    Active - Recruiting

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