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Brain MetastasesNeoSTROBENCT06933199

Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

A study testing Neoadjuvant Stereotactic Radiotherapy (NaSRT) and Postoperative Stereotactic Radiotherapy (SRT) in people with Brain Metastases, run by University Hospital Ostrava at 4 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
Neoadjuvant Stereotactic Radiotherapy (NaSRT) and Postoperative Stereotactic Radiotherapy (SRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
4 sitesCzechia
Study dates
1 May 2025to 31 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

  • Age ≥ 18 years
  • Karnofsky Performance Status ≥ 60
  • Histologically verified primary cancer disease
  • MRI findings indicating BM
  • Target BM indicated for surgical resection and any other metastases suitable for radical SRT.
  • Target BM between 1 cm and 7 cm at the longest diameter on T1 post-contrast MR imaging

Who cannot join

  • Confirmed hematological malignity
  • Small-cell (lung) carcinoma
  • Peracute condition requiring immediate neurosurgical intervention
  • History of whole-brain radiotherapy (WBRT)
  • History of stereotactic radiotherapy to a target brain metastasis
  • Pregnancy
  • Inability to perform surgical resection of the target BM within 7 days after NaSRT

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Czechia4 sites, 4 recruiting

  • Masaryk Memorial Cancer Institute

    Brno, 65653

    Tomáš Kazda, Assoc. Prof., MD, PhD, 0042072544 ext. 0509, tomas.kazda@mou.cz

    Tomáš Kazda, Assoc. Prof., MD, PhD

    Recruiting

  • University Hospital Hradec Králové

    Hradec Králové, 50005

    Igor Sirák, Assoc. Prof., MD, PhD, 00420608100251, igor.sirak@fnhk.cz

    Igor Sirák, Assoc. Prof., MD, PhD

    Recruiting

  • University Hospital Olomouc

    Olomouc, 77900

    Martin Doležel, prof., MD, PhD, 0042073713 ext. 0111, dolezelm@email.cz

    Martin Doležel, prof., MD, PhD

    Recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Jakub Cvek, Assoc.Prof.,MD, Ing., PhD, MBA

    Recruiting

Other trials in Czechia

About this study

Official title: Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE

This multicentre proof-of-concept study, involving 4 centers, aims to establish the value of fractionated neoadjuvant stereotactic radiotherapy (NaSRT) as a new treatment paradigm for brain metastases (BM) in the frame of the Czech neurooncology network. Most relevant studies published to date used single-fraction radiotherapy and dealt with the inherent bias related to their retrospective nature. The researchers aim to increase the level of evidence for this treatment paradigm together with other similar ongoing studies.

Read the detailed description

The prospective study will evaluate the efficacy and toxicity of neoadjuvant stereotactic radiotherapy (NaSRT) in patients with brain metastases (BM). Clinical data gathered will include local control (LC), the incidence of leptomeningeal disease (LMD), radiological and clinical signs of radiation necrosis (RN), overall survival, and incidence of metachronous brain metastases. The magnetic resonance imaging (MRI) characteristics of irradiated and subsequently resected BM will be obtained according to the usual protocol and specified time intervals. Clinical monitoring will comprise neurological findings, Karnofsky performance status, and quality of life (FACT-Br/EORTC QLQ-C30 questionnaire and EORTC QLQ-BN20 questionnaire. These questionnaires are designed to measure cancer patients' physical, psychological, and social functions. The questionnaires are composed of multi-item scales and single items). The data obtained from the retrospective control group (estimated for 160 patients) will include the same parameters monitored in the consecutive group of patients who underwent surgery at centers included in our study, with or without adjuvant radiotherapy (RT). Formation of this control group corresponding to the NaSRT group will enable the efficacy and risks of NaSRT to be determined in comparison with established treatment modalities.

Being tested
Neoadjuvant Stereotactic Radiotherapy (NaSRT), Postoperative Stereotactic Radiotherapy (SRT)
Keywords
Brain Metastases, Neoadjuvant Stereotactic Radiotherapy, Leptomeningeal Disease, Quality of Life, Overall Survival, Acute Toxicity
Medical subject headings
Brain Neoplasms, Meningeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant Stereotactic Radiotherapy (NaSRT)Radiation

    Neoadjuvant Stereotactic Radiotherapy (NaSRT) gives radiotherapy before surgery from many different angles around the body. The beams meet at the tumor. This means the tumor receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.

  • Postoperative Stereotactic Radiotherapy (SRT)Radiation

    Postoperative Stereotactic Radiotherapy (SRT) gives radiotherapy after surgery from many different angles around the body. The beams meet at the tumor. This means the tumor receives a high dose of radiation and the tissues around it receive a much lower dose. This lowers the risk of side effects.

Study groups in NCT06933199
Study groupRoleWhat they receive
Neoadjuvant NaSRT - prospectiveExperimentalPatients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.
Receives: Radiation: Neoadjuvant Stereotactic Radiotherapy (NaSRT)
Postoperative SRT - retrospectiveActive comparatorPatients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.
Receives: Radiation: Postoperative Stereotactic Radiotherapy (SRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Toxicity

    Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.

    Measured: 3 months

  2. Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30)

    Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire.

    Measured: 3 months

  3. Quality of Life Questionnaire (EORTC QLQ-BN20)

    Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire.

    Measured: 3 months

Secondary outcomes (5)

  1. Time from NaSRT to local progression

    Time from NaSRT to local progression will be assessed.

    Measured: 3 years

  2. Time from NaSRT to detection of LMD

    Time from NaSRT to detection of LMD will be assessed.

    Measured: 3 years

  3. Time from NaSRT to the onset of RN

    Time from NaSRT to the onset of RN will be assessed.

    Measured: 3 years

  4. Time from NaSRT to detection of distant parenchymal metastasis

    Time from NaSRT to detection of distant parenchymal metastasis will be assessed.

    Measured: 3 years

  5. Overall Survival

    Overall survival from NaSRT to death from any reason will be assessed.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
The study will include two groups of study subjects, enrolled prospectively and analysed retrospectively
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06933199
Sponsor's protocol ID
ONK-NeoSTROBE
Other IDs
NW25-03-00278
Acronym
NeoSTROBE
Status last verified
May 2025
First submitted
3 Apr 2025
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • DeAngelis LM, Delattre JY, Posner JB. Radiation-induced dementia in patients cured of brain metastases. Neurology. 1989 Jun;39(6):789-96. doi: 10.1212/wnl.39.6.789.

    PubMed 2725874

  • CHAO JH, PHILLIPS R, NICKSON JJ. Roentgen-ray therapy of cerebral metastases. Cancer. 1954 Jul;7(4):682-9. doi: 10.1002/1097-0142(195407)7:43.0.co;2-s. No abstract available.

    PubMed 13172684

  • Gavrilovic IT, Posner JB. Brain metastases: epidemiology and pathophysiology. J Neurooncol. 2005 Oct;75(1):5-14. doi: 10.1007/s11060-004-8093-6.

    PubMed 16215811

  • Barnholtz-Sloan JS, Sloan AE, Davis FG, Vigneau FD, Lai P, Sawaya RE. Incidence proportions of brain metastases in patients diagnosed (1973 to 2001) in the Metropolitan Detroit Cancer Surveillance System. J Clin Oncol. 2004 Jul 15;22(14):2865-72. doi: 10.1200/JCO.2004.12.149.

    PubMed 15254054

  • Linskey ME, Andrews DW, Asher AL, Burri SH, Kondziolka D, Robinson PD, Ammirati M, Cobbs CS, Gaspar LE, Loeffler JS, McDermott M, Mehta MP, Mikkelsen T, Olson JJ, Paleologos NA, Patchell RA, Ryken TC, Kalkanis SN. The role of stereotactic radiosurgery in the management of patients with newly diagnosed brain metastases: a systematic review and evidence-based clinical practice guideline. J Neurooncol. 2010 Jan;96(1):45-68. doi: 10.1007/s11060-009-0073-4. Epub 2009 Dec 4.

    PubMed 19960227

Questions about this trial

What is this clinical trial studying?

A study testing Neoadjuvant Stereotactic Radiotherapy (NaSRT) and Postoperative Stereotactic Radiotherapy (SRT) in people with Brain Metastases, run by University Hospital Ostrava at 4 sites in Czechia.

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 6 inclusion and 7 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia. 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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Toxicity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06933199, which also lists 5 linked publications.

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 May 2025.

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