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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • X-ray stereotactic radiotherapy for brain metastasis

    Device

    X-ray stereotactic radiotherapy for brain metastasis

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

LC rate

Local-control rate at third month after last treatment

Time frame
3 months

Secondary outcomes

1

Intracranial Toxicity

Intracranial Toxicity at first and third month after last treatment

Time frame
3months
2

ORR

Objective Response Rate at first and third month after last treatment

Time frame
3months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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