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| ID | Type | Description | Link |
|---|---|---|---|
| NW25-03-00278 | Other Grant/Funding Number | Ministry of Health of the Czech Republic |
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| Name | Class |
|---|---|
| University Hospital Olomouc | OTHER |
| Masaryk Memorial Cancer Institute | OTHER |
| University Hospital Hradec Kralove | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant NaSRT - prospective | Experimental | Patients undergoing neoadjuvant NaSRT will be enrolled prospectively in this study arm. |
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| Postoperative SRT - retrospective | Active Comparator | Patients who underwent postoperative SRT in the past will be analyzed retrospectively in this study arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%. | 3 months |
| Quality of Life Questionnaire (FACT-Br/EORTC QLQ-C30) | Quality of Life will be assessed in the study subjects using the FACT-Br/EORTC QLQ-C30 questionnaire. | 3 months |
| Quality of Life Questionnaire (EORTC QLQ-BN20) | Quality of Life will be assessed in the study subjects using the EORTC QLQ-BN20 questionnaire. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from NaSRT to local progression | Time from NaSRT to local progression will be assessed. | 3 years |
| Time from NaSRT to detection of LMD | Time from NaSRT to detection of LMD will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jakub Cvek, Assoc.Prof., MD, Ing, PhD, MBA | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2725874 | Background | DeAngelis 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. | |
| 13172684 | Background | CHAO 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. |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008577 | Meningeal Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The study will include two groups of study subjects, enrolled prospectively and analysed retrospectively
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No masking will be used in the study.
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| 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. |
|
| 3 years |
| Time from NaSRT to the onset of RN | Time from NaSRT to the onset of RN will be assessed. | 3 years |
| Time from NaSRT to detection of distant parenchymal metastasis | Time from NaSRT to detection of distant parenchymal metastasis will be assessed. | 3 years |
| Overall Survival | Overall survival from NaSRT to death from any reason will be assessed. | 3 years |
| Masaryk Memorial Cancer Institute | Recruiting | Brno | 65653 | Czechia |
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| University Hospital Hradec Králové | Recruiting | Hradec Králové | 50005 | Czechia |
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| University Hospital Olomouc | Recruiting | Olomouc | 77900 | Czechia |
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| 16215811 | Background | Gavrilovic IT, Posner JB. Brain metastases: epidemiology and pathophysiology. J Neurooncol. 2005 Oct;75(1):5-14. doi: 10.1007/s11060-004-8093-6. |
| 15254054 | Background | 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. |
| 19960227 | Background | 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. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |