Neoadjuvant Stereotactic Radiotherapy for Brain Metastases
Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE
This study is testing a new type of targeted radiation therapy for people with brain metastases to see if it can improve their survival and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Ostrava, Moravian-Silesian Region and 3 other locations) |
| Trial ID | NCT06933199 on ClinicalTrials.gov |
What this trial studies
This multicenter proof-of-concept study evaluates the efficacy and safety of neoadjuvant stereotactic radiotherapy (NaSRT) for patients with brain metastases. The study aims to gather clinical data on local control, overall survival, and quality of life, while comparing outcomes with a retrospective control group. Patients will undergo MRI assessments and complete quality of life questionnaires to monitor their physical and psychological well-being. The goal is to establish NaSRT as a new treatment paradigm within the Czech neurooncology network.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically verified primary cancer and brain metastases suitable for surgical resection.
Not a fit: Patients with hematological malignancies, small-cell lung carcinoma, or those requiring immediate neurosurgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve local control and overall survival for patients with brain metastases.
How similar studies have performed: While previous studies have focused on single-fraction radiotherapy, this approach of fractionated NaSRT is novel and aims to provide a higher level of evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ostrava, Moravian-Silesian Region and 3 other locations
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (Recruiting)
- Masaryk Memorial Cancer Institute — Brno, Czechia (Recruiting)
- University Hospital Hradec Králové — Hradec Králové, Czechia (Recruiting)
- University Hospital Olomouc — Olomouc, Czechia (Recruiting)
Study contacts
- Principal investigator: Jakub Cvek, Assoc.Prof., MD, Ing, PhD, MBA — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.