Clinical trial · Interventional
Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis
Neoadjuvant Stereotactic Radiotherapy for Brain Metastasis - Prospective Trial NeoSTROBE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Stereotactic Radiotherapy (NaSRT) | Radiation | — | UNRESOLVED |
| Postoperative Stereotactic Radiotherapy (SRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant NaSRT - prospective
- description
- Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm.
- interventionNames
- Radiation: Neoadjuvant Stereotactic Radiotherapy (NaSRT)
- type
- ACTIVE_COMPARATOR
- label
- Postoperative SRT - retrospective
- description
- Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm.
- interventionNames
- Radiation: Postoperative Stereotactic Radiotherapy (SRT)
Primary outcomes (3)
- measure
- Acute Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDDeAngelis 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. PMID 2725874
- BACKGROUNDCHAO 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. PMID 13172684
- BACKGROUNDGavrilovic IT, Posner JB. Brain metastases: epidemiology and pathophysiology. J Neurooncol. 2005 Oct;75(1):5-14. doi: 10.1007/s11060-004-8093-6. PMID 16215811
- BACKGROUNDBarnholtz-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. PMID 15254054
- BACKGROUNDLinskey 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. PMID 19960227