Brain Metastases, AdultPREOP-2NCT05124236
Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
A study testing preoperative radiosurgery and postoperative hypofractionated stereotactic radiotherapy in people with Brain Metastases, Adult, run by Susanne Rogers at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- preoperative radiosurgery and postoperative hypofractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 29 Jul 2022to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Switzerland6 sites, 6 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Susanne J Rogers, MD PhD, 0041628385726, susanne.rogers@ksa.ch
Sonja Schwenne, 0041628386259, sonja.schwenne@ksa.ch
- Recruiting
Inselspital, Universitätsklinik für Radio-Onkologie
Bern, Freiburgstrasse, 3010
Ekin Ermis, Dr. med., +41 31 632 26 32, erkin.ermis@insel.ch
- Recruiting
Kantonsspital Graubünden
Chur, 7000
Thomas Mader, Dr. med., +41 81 256 64 90, thomas.mader@ksgr.ch
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Gabriela Studer, Prof. Dr. med., +41 205 58 01, gabriela.studer@luks.ch
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9000
Detlef Brugge, Dr. med., +41 71 494 2192, detlef.brugge@kssg.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, 8400
Christoph Oehler, PD Dr. med., +41 52 266 26 58, christoph.oehler@ksw.ch
Germany3 sites, 3 recruiting
- Recruiting
Knappschaft Kliniken, Universitätsklinikum Bochum GmbH
Bochum
Dorothea Miller, Dr. med., Dorothea.Miller@Knappschaft-Kliniken.de
- Recruiting
UKGM-Giessen
Giessen
Daniel Hebermehl, Daniel.Habermehl@uk-gm.de
- Recruiting
Universitätsklinikum Schleswig Holstein
Kiel, 24103
Michael Synowitz, Prof. Dr. med., 0049 431-50023601, Michael.Synowitz@uksh.de
Oliver Blanck, Priv.-Doz. Dr., +49 431 50026666, oliver.blanck@uksh.de
About this study
Official title: A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
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.
Read the detailed description
Neurosurgical resection of a brain metastasis in patients with a diagnosis of cancer may be indicated however the recurrence rate approximates 50% and adjuvant radiotherapy is standard. Single fraction postoperative stereotactic radiosurgery (SRS) has been widely adopted as a standard therapy as it achieves equivalent survival and prevents loss of neurocognitive function as compared with whole brain radiotherapy and improves cavity local control rates as compared with observation. Hypofractionated stereotactic radiotherapy in 3 to 5 fractions (hfSRT) is also used in the postoperative setting.
Nodular leptomeningeal disease (nLMD) is a recognised pattern of failure after postoperative SRS and hfSRT. A 16.9% incidence of nodular LMD was seen after surgery and a similar incidence of 11%-28%is reported following postoperative SRS in retrospective series. These data suggest that postoperative SRS/hfSRT have no significant effect on the development of LMD following surgery.
The incidence of LMD following single fraction preoperative SRS is only 6.1% according to the largest retrospective series. Preoperative SRS takes advantage of the easier delineation of an intact BM and sterilizes tumor cells disseminated at surgery. Side effects are minimized by a smaller planning margin, a dose reduction and resection of the irradiated volume. In addition, there is no delay to systemic therapy due to wound healing/complications. Furthermore, a single fraction offers patient convenience.
This trial will randomise and compare intracranial outcomes between single fraction preoperative SRS and 5 fraction postoperative hFSRT.
- Conditions
- Brain Metastases, Adult
- Being tested
- preoperative radiosurgery, postoperative hypofractionated stereotactic radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative radiosurgeryRadiation
single fraction radiosurgery
postoperative hypofractionated stereotactic radiotherapyRadiation
fractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care
| Study group | Role | What they receive |
|---|---|---|
| Preoperative radiosurgery | Experimental | The interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection. Receives: 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. Receives: Radiation: postoperative hypofractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptomeningeal disease
time to leptomeningeal disease
Measured: 12 months after intervention
Secondary outcomes (4)
Local control of the surgical cavity
No evidence of tumour recurrence on contrast-enhanced MRI
Measured: 12 months after intervention
Distant brain failure
New brain metastases
Measured: 12 months after intervention
Radionecrosis
Adverse radiation effects
Measured: 12 months after intervention
Quality of life assessment
EORTC questionnaire core questionnaire QLQ30, EORTC questionnaire brain module BN 20 (1-4, low scores reflect better QoL)
Measured: 3,6,12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start29 Jul 2022
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susanne Rogers
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor-investigator, Susanne Rogers, Kantonsspital Aarau
- Investigators
- Susanne Rogers, MD PhD, Principal investigator, Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124236
- Sponsor's protocol ID
- 410.000.146
- Acronym
- PREOP-2
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective, Interventional, Randomized Trial of Preoperative Radiosurgery Compared With Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases
- ClinicalTrials.gov ID
- NCT05124236
- Acronym / sponsor ID
- PREOP-2 / 410.000.146
- Conditions
- Brain Metastases, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Susanne RogersUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurosurgical resection of a brain metastasis in patients with a diagnosis of cancer may be indicated however the recurrence rate approximates 50% and adjuvant radiotherapy is standard. Single fraction postoperative stereotactic radiosurgery (SRS) has been widely adopted as a standard therapy as it achieves equivalent survival and prevents loss of neurocognitive function as compared with whole brain radiotherapy and improves cavity local control rates as compared with observation. Hypofractionated stereotactic radiotherapy in 3 to 5 fractions (hfSRT) is also used in the postoperative setting.
Nodular leptomeningeal disease (nLMD) is a recognised pattern of failure after postoperative SRS and hfSRT. A 16.9% incidence of nodular LMD was seen after surgery and a similar incidence of 11%-28%is reported following postoperative SRS in retrospective series. These data suggest that postoperative SRS/hfSRT have no significant effect on the development of LMD following surgery.
The incidence of LMD following single fraction preoperative SRS is only 6.1% according to the largest retrospective series. Preoperative SRS takes advantage of the easier delineation of an intact BM and sterilizes tumor cells disseminated at surgery. Side effects are minimized by a smaller planning margin, a dose reduction and resection of the irradiated volume. In addition, there is no delay to systemic therapy due to wound healing/complications. Furthermore, a single fraction offers patient convenience.
This trial will randomise and compare intracranial outcomes between single fraction preoperative SRS and 5 fraction postoperative hFSRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative radiosurgery | Experimental | Radiation: preoperative radiosurgeryThe interventional arm is single fraction preoperative radiosurgery to a brain metastasis identified for neurosurgical resection. |
| Postoperative hypofractionated stereotactic radiotherapy | Active comparator | Radiation: postoperative hypofractionated stereotactic radiotherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative radiosurgerysingle fraction radiosurgery | Radiation | Preoperative radiosurgery |
| postoperative hypofractionated stereotactic radiotherapyfractionated stereotactic radiotherapy /radiosurgery in 1 to 6 fractions according to local standard of care | Radiation | Postoperative hypofractionated stereotactic radiotherapy |
Primary outcome
Leptomeningeal disease
Time frame: 12 months after intervention
time to leptomeningeal disease
4 secondary outcomes
Local control of the surgical cavity
Time frame: 12 months after intervention
Distant brain failure
Time frame: 12 months after intervention
Radionecrosis
Time frame: 12 months after intervention
Quality of life assessment
Time frame: 3,6,12 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Rogers, MD PhD principal investigator
Kantonsspital Aarau, Radio-Onkologie-Zentrum Mittelland
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative radiosurgery and postoperative hypofractionated stereotactic radiotherapy in people with Brain Metastases, Adult, run by Susanne Rogers at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Rogers, MD PhD (+41 62 838 57 26, Susanne.rogers@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptomeningeal disease (time frame: 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.