Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
NCT ID: NCT05588206
Last Updated: 2022-10-20
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
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2022-01-01
2024-12-31
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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Hypofractionated Stereotactic Radiotherapy for Brain Metastases
Hypofractionated Stereotactic Radiotherap
A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.
Interventions
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Hypofractionated Stereotactic Radiotherap
A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.
Eligibility Criteria
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Inclusion Criteria
* 1 to 10 brain metastases detected by magnetic resonance imaging (MRI)
* A life expectancy of \>3 months according to the DS GPA.
* KPS ≥70
* Control of the primary lesions (thorax) at the time of SBRT
* 2cm\<Tumor size ≤ 4 cm
* Age of 18-75 years old
* Patients must be able to undergo contrast enhanced MRI for planning
* Adequate bone marrow and organ function
Exclusion Criteria
* Prior surgery to brain metastasis
* Prior brain radiotherapy
* Non-small cell lung cancer with more than 10 brain metastases detected by MRI
* Contraindication to receiving radiotherapy.
18 Years
ALL
No
Sponsors
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Hangzhou Cancer Hospital
OTHER
First People's Hospital of Hangzhou
OTHER
Responsible Party
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Locations
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Kaicheng Pan
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DeHSRT
Identifier Type: -
Identifier Source: org_study_id
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