Brain MetastasisNCT06852001
Efficacy of the RayerKnife X Stereotactic Radiotherapy System in the Treatment of Brain Metastases
A study testing X-ray stereotactic radiotherapy for brain metastasis in people with Brain Metastasis and SRS, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Metastasis, SRS
- What is being tested?
- X-ray stereotactic radiotherapy for brain metastasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
- Conditions
- Brain Metastasis, SRS
- Being tested
- X-ray stereotactic radiotherapy for brain metastasis
- Keywords
- Radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray stereotactic radiotherapy for brain metastasisDevice
X-ray stereotactic radiotherapy for brain metastasis
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Device: X-ray stereotactic radiotherapy for brain metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
LC rate
Local-control rate at third month after last treatment
Measured: 3 months
Secondary outcomes (2)
Intracranial Toxicity
Intracranial Toxicity at first and third month after last treatment
Measured: 3months
ORR
Objective Response Rate at first and third month after last treatment
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852001
- Sponsor's protocol ID
- RK-RDCT-2024-2
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06852001
- Acronym / sponsor ID
- RK-RDCT-2024-2
- Conditions
- Brain Metastasis, SRS
- Keywords
- Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: X-ray stereotactic radiotherapy for brain metastasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-ray stereotactic radiotherapy for brain metastasisX-ray stereotactic radiotherapy for brain metastasis | Device | Experimental Group |
Primary outcome
LC rate
Time frame: 3 months
Local-control rate at third month after last treatment
2 secondary outcomes
Intracranial Toxicity
Time frame: 3months
ORR
Time frame: 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing X-ray stereotactic radiotherapy for brain metastasis in people with Brain Metastasis and SRS, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LC rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.