Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
170 participants
INTERVENTIONAL
2019-07-01
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FSRT
3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.
Fractionated stereotactic radiotherapy(FSRT)
3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.
Interventions
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Fractionated stereotactic radiotherapy(FSRT)
3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.
Eligibility Criteria
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Inclusion Criteria
* Age\>18 years.
* 1 to 10 brain metastases confirmed by enhanced brain MRI
* KPS≥70
* Life expectancy of more than 12 weeks
* Prior therapy of oral dexamethasone not exceeding 16mg/d
* Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
* Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
* Prior endocrine therapy were allowed
* Anti-Her2 targeted treatment were allowed
* Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
* Time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-Her2 targeted treatment are allowed to be used concurrently with FSRT
* Signed the informed consent form prior to patient entry
Exclusion Criteria
* Uncontrolled epilepsy
* Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
* Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
* Inability to complete enhanced MRI
* Patients who are difficult or unable to be followed-up
* Not suitable for inclusion for specific reasons judged by sponsor
* Patients who are receiving cytotoxic drug concomitantly
* Have received prior radiotherapy for brain metastasis
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDRT-BC009
Identifier Type: -
Identifier Source: org_study_id
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