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NCT Number: NCT06933199

Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acute Toxicity

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

Secondary outcomes

  1. Time from NaSRT to local progression

    Time frame: 3 years

    Time from NaSRT to local progression will be assessed.

  2. Time from NaSRT to detection of LMD

    Time frame: 3 years

    Time from NaSRT to detection of LMD will be assessed.

  3. Time from NaSRT to the onset of RN

    Time frame: 3 years

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

  4. Time from NaSRT to detection of distant parenchymal metastasis

    Time frame: 3 years

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

  5. Overall Survival

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Masaryk Memorial Cancer Institute
  • University Hospital Hradec Kralove
  • University Hospital Olomouc

Registry information

Official study title

Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE

Acronym: NeoSTROBE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 18, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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