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

December 9, 2022 updated by: University of Erlangen-Nürnberg Medical School

Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

382

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Klinik für Radioonkologie und Strahlentherapie Charité Berlin
        • Contact:
      • Erlangen, Germany, 91054
        • Recruiting
        • Erlangen, Universitätsklinikum Strahlenklinik
        • Contact:
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70174
        • Recruiting
        • Klinik für Strahlentherapie und Radioonkologie Stuttgart
        • Contact:
    • Bayern
      • Bayreuth, Bayern, Germany, 95445
        • Recruiting
        • Klinik für Strahlentherapie Bayreuth
        • Contact:
          • Ludwig Keilholz, Prof. Dr.
          • Phone Number: 0921 400-6802
      • Coburg, Bayern, Germany, 96450
        • Recruiting
        • Strahlentherapie Coburg
        • Contact:
      • Hof, Bayern, Germany, 95032
      • Kempten, Bayern, Germany, 87439
      • München, Bayern, Germany, 81675
        • Recruiting
        • Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)
        • Contact:
          • Denise Bernhardt, PD Dr.
          • Phone Number: +49 89 4140 4501
      • Regensburg, Bayern, Germany, 93053
        • Recruiting
        • Klinik und Poliklinik für Strahlentherapie Regensburg
        • Contact:
          • Oliver Kölbl, Prof. Dr.
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09113
        • Recruiting
        • Klink und Praxis für Radioonkologie Chemnitz
        • Contact:
          • Gunther Klautke, PD Dr. med.
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Recruiting
        • Universitätsklinik und Poliklinik für Strahlentherapie Halle
        • Contact:
    • Thüringen
      • Jena, Thüringen, Germany, 07745
        • Recruiting
        • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Radiation: Radiosurgery
Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
Other: Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin
Radiation: Fractionated stereotactic radiotherapy
Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to local progression - TTLP
Time Frame: 12 months

Local progression will be defined according to the RANO-BM criteria by an increase of at least 20% in the longest diameter of the metastasis relative to nadir or baseline. In addition to the relative increase of 20% the lesion must increase by an absolute value of 5 mm or more.

TTLP is defined as the time from randomization until the detection of progression as per the RANO-BM criteria. Patients will be censored if they have no signs of local progression at the time of last tumor monitoring during follow-up or at the onset of one of the following competing risk events not associated with local progression: death, lost to follow up, unauthorized non-protocol treatment of the target lesion.

Confirmatory analysis of the primary endpoint variable will be performed using a p-value of p≤0.05 as the global significance level.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CNS toxicity according to CTCAE v5.0
Time Frame: 12 months
CNS toxicity according to CTCAE v5.0
12 months
Time to local progression (Volumetric RANO-BM criteria)
Time Frame: 12 months
Based on the RANO-BM criteria, progression is defined as an increase in volume of 72.8% or more (corresponds to a 20% increase in diameter for a perfect sphere).
12 months
Quality of Life according to EORTC QLQ-C30
Time Frame: Change from baseline to 3, 6, 12 and 24 months
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ C30
Change from baseline to 3, 6, 12 and 24 months
Local-Progression-Free Survival
Time Frame: 12 months
Local-Progression-Free Survival is defined like TTLP except that death not associated with local progression will not be censored but assessed as a separate event
12 months
Overall Survival
Time Frame: 24 months
Overall Survival
24 months
Quality of Life according to EORTC QLQ-BN20
Time Frame: Change from baseline to 3, 6, 12 and 24 months
Quality of life measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ BN20
Change from baseline to 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Rainer Fietkau, Prof., Universitätsklinikum Erlangen, Strahlenklinik
  • Principal Investigator: Florian Putz, PD Dr.med., Universitätsklinikum Erlangen, Strahlenklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2021

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSRT-Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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