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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
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) 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.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
RECRUITINGMasaryk Memorial Cancer Institute
Brno, Czechia
RECRUITINGUniversity Hospital Hradec Králové
Hradec Králové, Czechia
RECRUITINGAcute Toxicity
Acute Toxicity will be assessed in the study subjects according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5 to 10%.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Time from NaSRT to local progression
Time from NaSRT to local progression will be assessed.
Time frame: 3 years
Time from NaSRT to detection of LMD
Time from NaSRT to detection of LMD will be assessed.
Time frame: 3 years
Time from NaSRT to the onset of RN
Time from NaSRT to the onset of RN will be assessed.
Time frame: 3 years
Time from NaSRT to detection of distant parenchymal metastasis
Time from NaSRT to detection of distant parenchymal metastasis will be assessed.
Time frame: 3 years
Overall Survival
Overall survival from NaSRT to death from any reason will be assessed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
260
University Hospital Olomouc
Olomouc, Czechia
RECRUITINGTime frame: 3 years