Clinical trial NCT06933199: Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis
Official title: Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: Brain Metastases
Neoadjuvant Stereotactic Radiotherapy
Leptomeningeal Disease
Quality of Life
Overall Survival
Acute Toxicity
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Olomouc
name: Masaryk Memorial Cancer Institute
name: University Hospital Hradec Kralove
First posted: 2025-04-18
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include two groups of study subjects, enrolled prospectively and analysed retrospectively
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acute Toxicity
timeFrame: 3 months
measure: Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30)
timeFrame: 3 months
measure: Quality of Life Questionnaire (EORTC QLQ-BN20)
timeFrame: 3 months
Secondary outcomes:
measure: Time from NaSRT to local progression
timeFrame: 3 years
measure: Time from NaSRT to detection of LMD
timeFrame: 3 years
measure: Time from NaSRT to the onset of RN
timeFrame: 3 years
measure: Time from NaSRT to detection of distant parenchymal metastasis
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Cvek, Assoc.Prof., MD, Ing, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gavrilovic IT, Posner JB. Brain metastases: epidemiology and pathophysiology. J Neurooncol. 2005 Oct;75(1):5-14. doi: 10.1007/s11060-004-8093-6.
citation: 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.
citation: 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.