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Not yet recruiting NCT06852001

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

No phase Interventional Brain Metastasis SRS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: X-ray stereotactic radiotherapy for brain metastasis.
Who it may be relevant to
Registry conditions: Brain Metastasis, SRS. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device X-ray stereotactic radiotherapy for brain metastasis
    X-ray stereotactic radiotherapy for brain metastasis

Primary outcome measures

  • LC rate [Time frame: 3 months]
Secondary outcome measures (2)
  • Intracranial Toxicity [Time frame: 3months]
  • ORR [Time frame: 3months]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 80 years (inclusive), regardless of gender.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Diagnosis of brain metastasis confirmed by histopathological examination and/or imaging, and deemed suitable for stereotactic radiotherapy according to the investigator's judgment.
  • Tumor diameter of brain metastasis ≤ 4 cm, with ≤ 10 metastatic lesions.
  • At least one measurable tumor lesion as defined by the RECIST 1.1 criteria for assessment of treatment efficacy.
  • 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

  • Expected survival time < 6 months.
  • Patients requiring surgical treatment or other local therapies for the target lesions during radiotherapy.
  • 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).
  • Patients who have previously received radiotherapy at the same site or for the same lesion.
  • Patients with extensive metastasis, severe cachexia, or clear signs of malignant cachexia.
  • Patients deemed by the investigator to be unable to tolerate radiotherapy.
  • Patients with psychiatric disorders or who are unable to accurately describe their condition or cooperate with required examinations.
  • Patients with systemic active infections or infections of the pericardium or lungs.
  • Patients with severe liver or renal dysfunction, or those with significant concurrent diseases in other systems.
  • Patients with septic hemorrhagic shock.
  • 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.
  • 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.).
  • 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.
  • Participation in any drug or medical device clinical trial within 30 days prior to screening or currently enrolled in another clinical study.
  • Any other condition deemed by the investigator to be inappropriate for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06852001 · RK-RDCT-2024-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗