Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases

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Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases

Study Purpose

The goal of this clinical trial is to evaluate the efficacy of stereotactic radiotherapy in the treatment of brain metastases. The main question it aims to answer is: Did stereotactic radiotherapy improve LC rate in the treatment of brain metastases? Participants will be recorded for local control rates during follow-up.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age between 18 and 80 years (inclusive), regardless of gender. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 3. Diagnosis of brain metastasis confirmed by histopathological examination and/or imaging, and deemed suitable for stereotactic radiotherapy according to the investigator's judgment. 4. Tumor diameter of brain metastasis ≤ 4 cm, with ≤ 10 metastatic lesions. 5. At least one measurable tumor lesion as defined by the RECIST 1.1 criteria for assessment of treatment efficacy. 6. Ability to understand the study objectives, voluntarily consent to participate, and sign a written informed consent; willingness to undergo all necessary examinations and follow-up assessments.

Exclusion Criteria:

1. Expected survival time < 6 months. 2. Patients requiring surgical treatment or other local therapies for the target lesions during radiotherapy. 3. Patients who have received other local treatments (including radiofrequency ablation, cryoablation, particle therapy, etc.) within 30 days prior to screening, or those who have received systemic therapy (chemotherapy, endocrine therapy, immunotherapy) within 14 days or less than five half-lives of a drug prior to screening (whichever is longer). 4. Patients who have previously received radiotherapy at the same site or for the same lesion. 5. Patients with extensive metastasis, severe cachexia, or clear signs of malignant cachexia. 6. Patients deemed by the investigator to be unable to tolerate radiotherapy. 7. Patients with psychiatric disorders or who are unable to accurately describe their condition or cooperate with required examinations. 8. Patients with systemic active infections or infections of the pericardium or lungs. 9. Patients with severe liver or renal dysfunction, or those with significant concurrent diseases in other systems. 10. Patients with septic hemorrhagic shock. 11. Patients with esophageal cancer at risk for deep ulceration or perforation, or those with large pleural effusion in lung cancer or significant ascites in abdominal tumors. 12. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or unwilling to take appropriate contraceptive measures (acceptable methods include hormonal therapies (oral, implant, etc.), intrauterine devices, barrier methods (spermicide + condom), spermicide + diaphragm/cervical cap, abstinence, etc.). 13. Low blood counts (leukocyte count < 2.0 × 10⁹/L, platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L), or abnormal laboratory values exceeding the normal range with clinical significance. 14. Participation in any drug or medical device clinical trial within 30 days prior to screening or currently enrolled in another clinical study. 15. Any other condition deemed by the investigator to be inappropriate for participation in this study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06852001
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tianjin Medical University Cancer Institute and Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastasis, SRS

Arms & Interventions

Arms

Experimental: Experimental Group

Interventions

Device: - X-ray stereotactic radiotherapy for brain metastasis

X-ray stereotactic radiotherapy for brain metastasis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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