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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03697343
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Erlangen-Nürnberg Medical School
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rainer Fietkau, Prof.Florian Putz, PD Dr.med.
Principal Investigator Affiliation Universitätsklinikum Erlangen, StrahlenklinikUniversitätsklinikum Erlangen, Strahlenklinik
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cerebral Metastases of Solid Cancers
Additional Details

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.

Arms & Interventions

Arms

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

Other: Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin

Interventions

Radiation: - Radiosurgery

Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)

Radiation: - Fractionated stereotactic radiotherapy

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Stuttgart, Baden-Württemberg, Germany

Status

Recruiting

Address

Klinik für Strahlentherapie und Radioonkologie Stuttgart

Stuttgart, Baden-Württemberg, 70174

Site Contact

Marc Münter, Prof. Dr.

[email protected]

0711 278-34201

Klinik für Strahlentherapie Bayreuth, Bayreuth, Bayern, Germany

Status

Recruiting

Address

Klinik für Strahlentherapie Bayreuth

Bayreuth, Bayern, 95445

Site Contact

Ludwig Keilholz, Prof. Dr.

[email protected]

0921 400-6802

Strahlentherapie Coburg, Coburg, Bayern, Germany

Status

Recruiting

Address

Strahlentherapie Coburg

Coburg, Bayern, 96450

Site Contact

Gerhard Grabenbauer, Prof. Dr.

[email protected]

09561 2491-0

Radio-Log Strahlentherapie Hof, Hof, Bayern, Germany

Status

Recruiting

Address

Radio-Log Strahlentherapie Hof

Hof, Bayern, 95032

Site Contact

Christoph Straube, PD Dr.

[email protected]

09281-140369 0

Strahlentherapie Süd Kempten, Kempten, Bayern, Germany

Status

Recruiting

Address

Strahlentherapie Süd Kempten

Kempten, Bayern, 87439

Site Contact

Sterzing, Prof. Dr.

[email protected]

+49(0)831 9607940

München, Bayern, Germany

Status

Recruiting

Address

Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM)

München, Bayern, 81675

Site Contact

Denise Bernhardt, PD Dr.

[email protected]

+49 89 4140 4501

Regensburg, Bayern, Germany

Status

Recruiting

Address

Klinik und Poliklinik für Strahlentherapie Regensburg

Regensburg, Bayern, 93053

Site Contact

Oliver Kölbl, Prof. Dr.

[email protected]

++49(0)9131-85-33405

Bonn, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Klinik für Strahlentherapie und Radioonkologie

Bonn, Nordrhein-Westfalen, 53127

Site Contact

Christopher Schmeel, PD Dr.

[email protected]

+49 228 287-10354

Halle, Sachsen-Anhalt, Germany

Status

Recruiting

Address

Universitätsklinik und Poliklinik für Strahlentherapie Halle

Halle, Sachsen-Anhalt, 06120

Site Contact

Christian Dietzel, Dr. med.

[email protected]

0345 557 4310

Chemnitz, Sachsen, Germany

Status

Recruiting

Address

Klink und Praxis für Radioonkologie Chemnitz

Chemnitz, Sachsen, 09113

Site Contact

Gunther Klautke, PD Dr. med.

[email protected]

++49(0)9131-85-33405

Jena, Thüringen, Germany

Status

Recruiting

Address

Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena

Jena, Thüringen, 07745

Site Contact

Andrea Wittig, Prof. Dr.

[email protected]

03641/9-328401

Berlin, Germany

Status

Recruiting

Address

Klinik für Radioonkologie und Strahlentherapie Charité Berlin

Berlin, , 13353

Site Contact

Felix Ehret, Dr. med.

[email protected]

+49 30 450 527 152

Erlangen, Germany

Status

Recruiting

Address

Erlangen, Universitätsklinikum Strahlenklinik

Erlangen, , 91054

Site Contact

Rainer Fietkau, Prof.

[email protected]

+499131-85-33405

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