Brain Metastases, AdultNCT07405047
Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases
A study testing fractionated stereotactic radiotherapy in people with Brain Metastases, Adult, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Adult
- What is being tested?
- fractionated stereotactic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary tumor is proved malignant by pathology;
- Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
- The maximum diameter of each lesion is ≤ 2cm;
- Age ≥ 18 years old;
- KPS≥ 70;
- Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
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- expected survival of more than 6 months;
- The functions of vital organs meet the requirements;
- The patients voluntarily join the clinical study and sign the informed consent.
Who cannot join
- Surgical intervention is considered for MDT consultation;
- Meningeal metastasis;
- The primary tumor is small cell lung cancer;
- Follow-up data can't be obtained regularly;
- patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color doppler examination;
- neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
- Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial
This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
Read the detailed description
This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.
- Conditions
- Brain Metastases, Adult
- Being tested
- fractionated stereotactic radiotherapy
- Keywords
- limited brain metastases, small brain metastases, fractionated stereotactic 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.
fractionated stereotactic radiotherapyRadiation
The prescription is 30 Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| fractionated stereotactic radiotherapy group | Experimental | fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions. Receives: Radiation: fractionated stereotactic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
local control without symptomatic radiation necrosis rate
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
Measured: 1 year after fractionated stereotactic radiotherapy (FSRT)
Secondary outcomes (6)
disease control rate
Complete release (CR) + partial release (PR) + stable disease (SD) rate, assessed by RECIST 1.1 criteria
Measured: 2 months after fractionated stereotactic radiotherapy (FSRT)
local control rate
local control rate of the lesions which received FSRT
Measured: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial distant failure rate
new brain metastases in the brain
Measured: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial progression free survival rate
local control without intra-cranial distant failure
Measured: 1 year after fractionated stereotactic radiotherapy (FSRT)
adverse events
neurological toxicity was determined according to RTOG acute toxicity classification criteria, and the rest was determined according to NCI-CTCAE V5.0 criteria
Measured: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
radiation necrosis rate
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
Measured: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Sep 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases, AdultStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YE ZHANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ye Zhang, MD., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405047
- Sponsor's protocol ID
- NCC-012829
- Status last verified
- Feb 2026
- First submitted
- 27 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD is protected by our institution and are not allowed to share to others.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial
- ClinicalTrials.gov ID
- NCT07405047
- Acronym / sponsor ID
- NCC-012829
- Conditions
- Brain Metastases, Adult
- Keywords
- limited brain metastases, small brain metastases, fractionated stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 12 Feb 2026 (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.
This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
Detailed description
This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fractionated stereotactic radiotherapy group | Experimental | Radiation: fractionated stereotactic radiotherapyfractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The primary tumor is proved malignant by pathology;
- Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
- The maximum diameter of each lesion is ≤ 2cm;
- Age ≥ 18 years old;
- KPS≥ 70;
Key exclusion criteria (7 listed)
- Surgical intervention is considered for MDT consultation;
- Meningeal metastasis;
- The primary tumor is small cell lung cancer;
- Follow-up data can't be obtained regularly;
- patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color doppler examination;
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 |
|---|---|---|
| fractionated stereotactic radiotherapyThe prescription is 30 Gy in 5 fractions. | Radiation | fractionated stereotactic radiotherapy group |
Primary outcome
local control without symptomatic radiation necrosis rate
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
6 secondary outcomes
disease control rate
Time frame: 2 months after fractionated stereotactic radiotherapy (FSRT)
local control rate
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial distant failure rate
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial progression free survival rate
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
adverse events
Time frame: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
radiation necrosis rate
Time frame: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. The IPD is protected by our institution and are not allowed to share to others.
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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. This study is not recruiting at the moment.
Ye Zhang, MD. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fractionated stereotactic radiotherapy in people with Brain Metastases, Adult, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
local control without symptomatic radiation necrosis rate (time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)). 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 12 Feb 2026.