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Compares treatment options for Brain Metastases, Adult
Official title Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
ClinicalTrials.gov ID: NCT05124236
What this study is testing
- What it's testing
- The research question is whether a single fraction of preoperative radiosurgery can reduce the incidence of leptomeningeal disease 12 months following resection of a brain metastasis (BM) as compared with 5 fractions of postoperative stereotactic radiotherapy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥18
- Karnofsky performance status ≥60
- Histological diagnosis of a malignant primary or metastatic tumour
You likely can't join if
- Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
- \>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
- More than 4 brain metastases or the diameter of the metastasis for resection \>4.0 cm.
- More than 1 metastasis requiring resection
- Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
- Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥18
- Karnofsky performance status ≥60
- Histological diagnosis of a malignant primary or metastatic tumour
- Ability to take steroids
- No contraindication to magnetic resonance imaging (MRI)
- MRI-diagnosis of a clearly demarcated contrast-enhancing brain metastasis up to 4.0 cm diameter indicated for neurosurgical resection (tumorboard decision). Up to 3 other brain metastases suitable for primary...
- Survival estimated by primary clinician \> 12 months
- Platelet count \> 100/ml, INR \ 7.5 g/dL
- Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
- \>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
- More than 4 brain metastases or the diameter of the metastasis for resection \>4.0 cm.
- More than 1 metastasis requiring resection
- Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
- Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
- Prior resection of a primary or secondary brain tumor
- Prior diagnosis of a non-meningioma brain tumor
- Prior radionuclide therapy within 30 days
- Prior anti-VEGF therapy within 6 weeks
- Unable to tolerate radiosurgery immobilization and treatment
- Inability to give informed consent
- Pregnancy or lactation
- Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy
- Males of reproductive potential not effective contraception for 3 months after radiotherapy
- Lack of likely compliance with protocol and follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Austria
- Bochum, Germany
- Giessen, Germany
- Kiel, Germany
- Aarau, Canton of Aargau, Switzerland
- Bern, Freiburgstrasse, Switzerland
- Chur, Switzerland
- Lucerne, Switzerland
- Sankt Gallen, Switzerland
- Winterthur, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Austria; Bochum, Germany; Giessen, Germany; Kiel, Germany; Aarau, Canton of Aargau, Switzerland; Bern, Freiburgstrasse, Switzerland and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.