EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
NCT ID: NCT02714010
Last Updated: 2017-10-27
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
PHASE3
601 participants
INTERVENTIONAL
2015-08-31
2022-12-31
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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Arm 1
Patients take EGFR-TKI alone till tumor progression
EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
Arm 2
Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
whole brain radiotherapy
30Gy/10F
Interventions
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EGFR-TKI
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
whole brain radiotherapy
30Gy/10F
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
* Appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm in brain (by brain MRI).
* Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin \> 10g/dl, absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L; total bilirubin \< 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）\< 1.5x ULN in the absence of liver metastases, or \< 5x ULN in case of liver metastases. Creatinine clearance \> 60ml/min (calculated according to Cockcroft-gault formula).
* Patients should be contraceptive during the period of the trial.
Exclusion Criteria
* Patients who can't receive WBRT.
* Uncontrolled intracranial hypertension after steroid or dehydration therapy.
* Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
* Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
* Patients who can't take oral tablets, with active peptic ulcer diseases.
* Pregnancy or breast-feeding women.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Li-kun Chen
Associate Professor/Associate chief physician
Principal Investigators
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li-kun Chen
Role: PRINCIPAL_INVESTIGATOR
associate chief physician
Locations
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Sun Yat-sen University of cancer center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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li-kun chen, doctor
Role: primary
Other Identifiers
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GASTO1014
Identifier Type: -
Identifier Source: org_study_id