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Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases | Clinical Trials | Clareo Health

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Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial

NCT07405047•Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The primary tumor is proved malignant by pathology;
•2. Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
•3. The maximum diameter of each lesion is ≤ 2cm;
•4. Age ≥ 18 years old;
•5. KPS≥ 70;
•6. Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
•7. expected survival of more than 6 months;
•8. The functions of vital organs meet the requirements;
•9. The patients voluntarily join the clinical study and sign the informed consent.

Exclusion Criteria

•1. Surgical intervention is considered for MDT consultation;
•2. Meningeal metastasis;
•3. The primary tumor is small cell lung cancer;
•4. Follow-up data can't be obtained regularly;
•5. 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;
•6. neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
•7. Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.

Locations (1)

Ye Zhang

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 1, 2022

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

February 12, 2026

Enrollment

ACTUAL participants

Conditions

Brain Metastases, Adult

Interventions

fractionated stereotactic radiotherapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

Inclusion Criteria

Exclusion Criteria

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