Comparing two radiation therapies for 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)
PHASE3 · University of Erlangen-Nürnberg Medical School · NCT03697343
This study is testing whether a series of smaller radiation treatments or a single larger treatment works better for people with larger brain tumors and how each option affects them.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 382 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Drugs / interventions | radiation |
| Locations | 13 sites (Stuttgart, Baden-Wurttemberg and 12 other locations) |
| Trial ID | NCT03697343 on ClinicalTrials.gov |
What this trial studies
This Phase III trial investigates the effectiveness and side effects of fractionated stereotactic radiotherapy versus single session radiosurgery in patients with larger brain metastases measuring 2-4 cm. Participants will be randomly assigned to receive either 12 sessions of 4 Gy fractionated radiotherapy or a single session of radiosurgery with varying doses based on the size of the metastasis. The study aims to evaluate local control of the cancer and the associated side effects of each treatment approach. Randomization will be stratified by the volume of metastasis and the type of cancer histology.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a Karnofsky Performance Score greater than 50 and 1-10 cerebral metastases from solid cancers.
Not a fit: Patients with contraindications for cerebral MRI or those who have had prior radiation to the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for patients with larger brain metastases, potentially improving local control and reducing side effects.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiotherapy approaches, but this specific comparison is novel.
Eligibility criteria
Show full 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
Where this trial is running
Stuttgart, Baden-Wurttemberg and 12 other locations
- Klinik für Strahlentherapie und Radioonkologie Stuttgart — Stuttgart, Baden-Wurttemberg, Germany (RECRUITING)
- Klinik für Strahlentherapie Bayreuth — Bayreuth, Bavaria, Germany (RECRUITING)
- Strahlentherapie Coburg — Coburg, Bavaria, Germany (RECRUITING)
- Radio-Log Strahlentherapie Hof — Hof, Bavaria, Germany (RECRUITING)
- Strahlentherapie Süd Kempten — Kempten (Allgäu), Bavaria, Germany (RECRUITING)
- Klinik und Poliklinik für RadioOnkologie und Strahlentherapie München (TUM) — München, Bavaria, Germany (RECRUITING)
- Klinik und Poliklinik für Strahlentherapie Regensburg — Regensburg, Bavaria, Germany (RECRUITING)
- Klinik für Strahlentherapie und Radioonkologie — Bonn, North Rhine-Westphalia, Germany (RECRUITING)
- Klink und Praxis für Radioonkologie Chemnitz — Chemnitz, Saxony, Germany (RECRUITING)
- Universitätsklinik und Poliklinik für Strahlentherapie Halle — Halle, Saxony-Anhalt, Germany (RECRUITING)
- Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Jena — Jena, Thuringia, Germany (RECRUITING)
- Klinik für Radioonkologie und Strahlentherapie Charité Berlin — Berlin, Germany (RECRUITING)
- Erlangen, Universitätsklinikum Strahlenklinik — Erlangen, Germany (RECRUITING)
Study contacts
- Principal investigator: Rainer Fietkau, Prof. — Universitätsklinikum Erlangen, Strahlenklinik
- Study coordinator: Florian Putz, PD Dr. med.
- Email: florian.putz@uk-erlangen.de
- Phone: ++49(0)9131-85-33405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Metastases of Solid Cancers