Brain Metastases
Conditions
Keywords
Brain Metastases, Neoadjuvant Stereotactic Radiotherapy, Leptomeningeal Disease, Quality of Life, Overall Survival, Acute Toxicity
Brief 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.
Detailed description
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.
Interventions
RADIATIONNeoadjuvant 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.
RADIATIONPostoperative 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.
Sponsors
University Hospital Olomouc
Masaryk Memorial Cancer Institute
University Hospital Hradec Kralove
University Hospital Ostrava
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking will be used in the study.
Intervention model description
The study will include two groups of study subjects, enrolled prospectively and analysed retrospectively
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from NaSRT to detection of distant parenchymal metastasis | 3 years | Time from NaSRT to detection of distant parenchymal metastasis will be assessed. |
| Time from NaSRT to local progression | 3 years | Time from NaSRT to local progression will be assessed. |
| Overall Survival | 3 years | Overall survival from NaSRT to death from any reason will be assessed. |
| Time from NaSRT to detection of LMD | 3 years | Time from NaSRT to detection of LMD will be assessed. |
| Time from NaSRT to the onset of RN | 3 years | Time from NaSRT to the onset of RN will be assessed. |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed