Comparing preoperative and postoperative radiation for brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates whether a single fraction of preoperative radiosurgery can lower the risk of leptomeningeal disease compared to five fractions of postoperative stereotactic radiotherapy in patients undergoing resection for brain metastases. The study aims to determine if preoperative treatment can effectively sterilize tumor cells and reduce recurrence rates while minimizing side effects and delays in systemic therapy. Participants will be monitored for 12 months following their surgery to assess the incidence of nodular leptomeningeal disease. The trial includes patients with a clear diagnosis of brain metastases who are eligible for surgical resection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age ≥18
4. Karnofsky performance status ≥60
5. Histological diagnosis of a malignant primary or metastatic tumour
6. Ability to take steroids
7. No contraindication to magnetic resonance imaging (MRI)
8. 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 radiosurgery/ stereotactic radiotherapy
9. Survival estimated by primary clinician \> 12 months
10. Platelet count \> 100/ml, INR \< 1.3, Hb \> 7.5 g/dL

Exclusion Criteria:

1. Radiosensitive histology: germ cell tumour, lymphoma, multiple myeloma
2. \>10 mm midline shift, effacement of the 4th ventricle or other sign of raised intracranial pressure requiring urgent decompressive surgery
3. More than 4 brain metastases or the diameter of the metastasis for resection \>4.0 cm.
4. More than 1 metastasis requiring resection
5. Leptomeningeal disease in the CSF or on MRI (unless localized and can be irradiated then resected with the metastasis)
6. Prior radiation to the brain (SRS/SRT to lesion to be resected and /or WBRT)
7. Prior resection of a primary or secondary brain tumor
8. Prior diagnosis of a non-meningioma brain tumor
9. Prior radionuclide therapy within 30 days
10. Prior anti-VEGF therapy within 6 weeks
11. Unable to tolerate radiosurgery immobilization and treatment
12. Inability to give informed consent
13. Pregnancy or lactation
14. Females of reproductive potential not willing to use effective contraception for at least 6 months after radiotherapy
15. Males of reproductive potential not effective contraception for 3 months after radiotherapy
16. Lack of likely compliance with protocol and follow-up

Where it's running

• Knappschaft Kliniken, Universitätsklinikum Bochum GmbH
  Bochum, Germany Recruiting
• UKGM-Giessen
  Giessen, Germany Recruiting
• Universitätsklinikum Schleswig Holstein
  Kiel, Germany Recruiting
• Kantonsspital Aarau
  Aarau, Canton of Aargau, Switzerland Recruiting
• Inselspital, Universitätsklinik für Radio-Onkologie
  Bern, Freiburgstrasse, Switzerland Recruiting
• Kantonsspital Graubünden
  Chur, Switzerland Recruiting

Study contacts

• Principal investigator: Susanne Rogers, MD PhD — Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland
• Study coordinator: Susanne Rogers, MD PhD
• Email: Susanne.rogers@ksa.ch
• Phone: +41 62 838 57 26

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.