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

A Prospective, Multi-center, Single-Arm Study on the Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Metastasis; SRS
• Intervention / Treatment: Device: X-ray stereotactic radiotherapy for brain metastasis

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	Device: X-ray stereotactic radiotherapy for brain metastasis; X-ray stereotactic radiotherapy for brain metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LC rate	Local-control rate at third month after last treatment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial Toxicity	Intracranial Toxicity at first and third month after last treatment	3months
ORR	Objective Response Rate at first and third month after last treatment	3months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Radiotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: RK-RDCT-2024-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No