The Role of Brain Radiotherapy in Patients With Asymptomatic Brain Metastasis in the Era of Targeted Therapy for NSCLC
NCT ID: NCT04193007
Last Updated: 2019-12-10
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
100 participants
INTERVENTIONAL
2019-12-01
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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molecular targeted therapy group
Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)
molecular targeted therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）
Brain Radiotherapy and molecular targeted therapy group
Brain Radiotherapy (stereotactic radiotherapy was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain )was used for more than 3 intracranial lesions);Molecular targeted therapy(according to the results of gene detection, targeted drugs were selected, such as EGFR mutation using the first generation of EGFR-TKI,ALK or ROS1 mutation using the first generation of ALK inhibitors)
molecular targeted therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）
Brain Radiotherapy
SRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions
Interventions
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molecular targeted therapies
if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）
Brain Radiotherapy
SRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* EGFR, ALK or ROS1 gene detection showed sensitive gene mutation, and patients were willing to receive targeted therapy;
* brain MRI confirmed brain metastasis;
* asymptomatic or symptomatic brain metastasis could be controlled by glucocorticoid;
* PS score 0-1;
* no brain radiotherapy or targeted therapy before entering the group;
* there was no history of malignant tumor and no serious medical diseases;
* Laboratory examination: White blood cell count ≥ 4 \*10\^9/L, neutrophil count ≥ 2.0 \*10\^9, platelet count ≥ 100 \*10\^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal;
* the pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptives during the experiment;
* sign informed consent form.
Exclusion Criteria
* other malignant tumors (unless PFS ≥ 3 years, except non-black skin cancer);
* were treated with brain radiotherapy or targeted therapy before;
* those with other potentially serious diseases (congestive heart failure, transmural myocardial infarction, admission with severe acute bacterial or fungal infection, COPD or other respiratory diseases that affect treatment, etc.), Taking into account that the study may exacerbate or fail to control the disease;
* severe immunosuppressive diseases, such as AIDS;
* pregnant women, lactating women or women of childbearing age who do not agree with the use of effective contraception in the trial;
* Intracranial metastasis with obvious symptoms or symptoms that can not be relieved by glucocorticoid alone
18 Years
80 Years
ALL
No
Sponsors
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Nanchang University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Responsible Party
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Principal Investigators
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Liu Anwen, Phd
Role: STUDY_DIRECTOR
Second Affiliated Hospital of Nanchang University
Locations
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The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Anwen Liu, MD
Role: primary
References
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Other Identifiers
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Y-Q201802-009
Identifier Type: -
Identifier Source: org_study_id