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Clinical Trials in Czechia / NCT06933199
Recruiting Not applicable

Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis

NCT06933199 · tracked via the Priya Life Science Czechia tracker
Sponsor
University Hospital Ostrava
Phase
Not applicable
Started
2025-05-01
Last updated
2025-05-04

Condition(s) studied

Brain Metastases

Investigational drug(s) / intervention(s)

Neoadjuvant Stereotactic Radiotherapy (NaSRT)Postoperative Stereotactic Radiotherapy (SRT)

Neoadjuvant Stereotactic Radiotherapy (NaSRT): 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): 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Acute Toxicity — 3 months
    Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.
  • Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30) — 3 months
    Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire.
  • Quality of Life Questionnaire (EORTC QLQ-BN20) — 3 months
    Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire.

Trial sites (4)

FacilityCityRegionStatus
University Hospital Ostrava Ostrava Moravian-Silesian Region Recruiting
Masaryk Memorial Cancer Institute Brno Czechia Recruiting
University Hospital Hradec Králové Hradec Králové Czechia Recruiting
University Hospital Olomouc Olomouc Czechia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06933199 on ClinicalTrials.gov ↗ ← All trials in Czechia