Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02714010 : EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
PhasePhase 3
AgesMin: 18 Years Max: 75 Years
Eligibility
Inclusion Criteria:

- Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or
cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).

- 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 had received brain radiotherapy or EGFR-TKI before.

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02714010      |      Link to official Clinicaltrials.gov listing
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