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

NCT05124236 | Recruiting DMC

• 1 other identifier: 410.000.146
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 10

Brief Summary

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

Brain Metastases, Adult

Outcome Measures

Primary Outcomes (1)

• Leptomeningeal disease

  time to leptomeningeal disease

  12 months after intervention

Secondary Outcomes (4)

• Local control of the surgical cavity

  12 months after intervention

• Distant brain failure

  12 months after intervention

• Radionecrosis

  12 months after intervention

• Quality of life assessment

  3,6,12 months after intervention

Study Arms (2)

Preoperative radiosurgery

EXPERIMENTAL

The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection.

Radiation: preoperative radiosurgery

Postoperative hypofractionated stereotactic radiotherapy

ACTIVE COMPARATOR

The active comparator arm is the standard of care of postoperative hypofractionated stereotactic radiotherapy to the surgical cavity in 5 fractions following resection of the brain metastasis.

Radiation: postoperative hypofractionated stereotactic radiotherapy

Interventions

preoperative radiosurgery RADIATION

single fraction radiosurgery

Preoperative radiosurgery

postoperative hypofractionated stereotactic radiotherapy RADIATION

fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care

Postoperative hypofractionated stereotactic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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 radiosurgery/ stereotactic radiotherapy
• Survival estimated by primary clinician \> 12 months
• Platelet count \> 100/ml, INR \< 1.3, Hb \> 7.5 g/dL

You may not qualify 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)
• 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

Sponsors & Collaborators

• Susanne Rogers: lead
• University of Basel: collaborator

Study Sites (10)

Tirol Kliniken Innsbruck

Innsbruck, 6020, Austria

ACTIVE NOT RECRUITING

Knappschaft Kliniken, Universitätsklinikum Bochum GmbH

Bochum, Germany

RECRUITING

UKGM-Giessen

Giessen, Germany

RECRUITING

Universitätsklinikum Schleswig Holstein

Kiel, 24103, Germany

RECRUITING

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Inselspital, Universitätsklinik für Radio-Onkologie

Bern, Freiburgstrasse, 3010, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9000, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8400, Switzerland

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Susanne Rogers, MD PhD

  Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Rogers, MD PhD

CONTACT

+41 62 838 57 26; Susanne.rogers@ksa.ch

Oliver Riesterer, Prof.

CONTACT

+41 62 838 4249; oliver.riesterer@ksa.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 17, 2021
• Study Start: July 29, 2022
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (1); CH (6)