Comparing preoperative and postoperative radiation for brain metastases

A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

This study tests if giving radiation before surgery for brain metastases can lower the chance of cancer spreading in the brain compared to giving it after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kantonsspital Aarau (other)
• Drugs / interventions: radiation
• Locations: 10 sites (Innsbruck and 9 other locations)
• Trial ID: NCT05124236 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of a malignant tumor and a clearly defined brain metastasis suitable for surgical resection.

Not a fit: Patients with radiosensitive tumors or those requiring urgent decompressive surgery due to raised intracranial pressure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of leptomeningeal disease in patients with brain metastases, improving their overall prognosis.

How similar studies have performed: Previous studies have indicated that preoperative radiosurgery may be effective, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Innsbruck and 9 other locations

• Tirol Kliniken Innsbruck — Innsbruck, Austria (ACTIVE_NOT_RECRUITING)
• 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)
• Luzerner Kantonsspital — Lucerne, Switzerland (RECRUITING)
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland (RECRUITING)
• Kantonsspital Winterthur — Winterthur, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Susanne Rogers, MD PhD — Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland
• Study coordinator: Susanne Rogers, MD PhD

Conditions: Brain Metastases, Adult