Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05124236

Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

Led by Susanne Rogers · Updated on 2026-03-04

200

Participants Needed

10

Research Sites

335 weeks

Total Duration

On this page

Sponsors

S

Susanne Rogers

Lead Sponsor

U

University of Basel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent
  • Willingness to follow study procedures and be available throughout the study
  • Age 18 years or older
  • Karnofsky performance status of 60 or higher
  • Histological confirmation of malignant primary or metastatic tumor
  • Ability to take steroids
  • No contraindication to MRI
  • MRI diagnosis of a clearly defined contrast-enhancing brain metastasis up to 4.0 cm planned for surgical removal
  • Up to 3 additional brain metastases suitable for radiosurgery
  • Estimated survival longer than 12 months
  • Platelet count above 100/ml, INR below 1.3, and hemoglobin above 7.5 g/dL
Not Eligible

You will not qualify if you...

  • Radiosensitive tumors such as germ cell tumors, lymphoma, or multiple myeloma
  • More than 10 mm midline brain shift or signs of raised intracranial pressure requiring urgent surgery
  • More than 4 brain metastases or the target metastasis larger than 4.0 cm
  • More than one metastasis needing surgical removal
  • Leptomeningeal disease in cerebrospinal fluid or on MRI unless localized and treatable with surgery and radiation
  • Prior brain radiation therapy including radiosurgery or whole brain radiation
  • Previous surgical removal of primary or secondary brain tumors
  • Previous diagnosis of non-meningioma brain tumors
  • Recent radionuclide therapy within 30 days
  • Recent anti-VEGF therapy within 6 weeks
  • Unable to tolerate radiosurgery immobilization or treatment
  • Unable to give informed consent
  • Pregnant or breastfeeding
  • Women of childbearing potential unwilling to use effective contraception for at least 6 months after radiation
  • Men unwilling to use effective contraception for 3 months after radiation
  • Unlikely to comply with study protocol and follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Tirol Kliniken Innsbruck

Innsbruck, Austria, 6020

Active, Not Recruiting

2

Knappschaft Kliniken, Universitätsklinikum Bochum GmbH

Bochum, Germany

Actively Recruiting

3

UKGM-Giessen

Giessen, Germany

Actively Recruiting

4

Universitätsklinikum Schleswig Holstein

Kiel, Germany, 24103

Actively Recruiting

5

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland, 5001

Actively Recruiting

6

Inselspital, Universitätsklinik für Radio-Onkologie

Bern, Freiburgstrasse, Switzerland, 3010

Actively Recruiting

7

Kantonsspital Graubünden

Chur, Switzerland, 7000

Actively Recruiting

8

Luzerner Kantonsspital

Lucerne, Switzerland, 6000

Actively Recruiting

9

Kantonsspital St. Gallen

Sankt Gallen, Switzerland, 9000

Actively Recruiting

10

Kantonsspital Winterthur

Winterthur, Switzerland, 8400

Actively Recruiting

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Research Team

S

Susanne Rogers, MD PhD

CONTACT

O

Oliver Riesterer, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases | DecenTrialz