Clinical Trial Details
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NCT01887795 : Phase ? Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as ?rst-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised Study
PhasePhase 3
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. 18 years of age or older;

2. the pathological diagnosis of non-small cell lung cancer and detection of pulmonary
primary ARMs / sequencing EGFR mutation;

3. enhanced MRI showed brain metastases ? 2 or NSCLC of brain metastases after resection
of residual lesions in ? 2 / intracranial metastases in patients with new;

4. if the previous use of EGFR-TKIs, in an WBRT synchronous Erotinib before treatment to
disable EGFR-TKIs ? 4 weeks;

5. expected survival period over 2 months;

6. KPS score ? 70;

7. GPA score 0.5 - 3.5;

8. a week before randomization, bone marrow and liver and kidney function in patients
with meet the following criteria:

1. HB ? 100, g/L ? 1.5 × 109/L neutrophil and platelet ? 100 × 109/L;

2. total bilirubin ? 1.5 times the upper limit of normal, aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ? 1.5 times the upper
limit of normal;

3. more than 1.5 times the upper limit of normal serum creatinine or creatinine
clearance rate ? 60 ml/min, urea N ? 200mg/L;

4. Urine dipstick testing the proteinuria < 1+; if the urine dipstick test value,
1+, is 24 hours total urine protein must < 500mg.

9. compliance research plan and follow-up process, and be able to carry out oral

10. in women of childbearing age, must be in before starting treatment within 7 day of
urine pregnancy test and the result is negative, and not in the lactation period, and
reproductive age men and women prior to entry into the study, the research process
until 90 days after stopping all agree to use reliable methods of contraception;

11. can understand and consent.

Exclusion Criteria:

1. patients have been treated with radiation to the brain or to erlotinib and its
ingredients allergies;

2. mixed with small cell lung cancer patients with components;

3. 5 years before other cancers except NSCLC treatment in patients with the start of the
study (except for simple operation resection and there are at least 5 consecutive
years disease free survival, has been cured of cervical carcinoma in situ, has cured
the base cell cancer and bladder epithelial tumor);

4. before entering the group 4 weeks received any other investigational drugs;

5. judgment according to the researchers, there are serious harm to patient safety or
affect the patients completed the study with the disease, and patient compliance with
the difference;

6. had any clinical evidence of moderate to severe chronic obstructive pulmonary disease
(COPD -COPD a history or risk factors of pulmonary function testing, FEV1/FVC<70%,
FEV1<80% estimates, with or without chronic cough, sputum, difficulty breathing),
activity of interstitial lung disease (-ILD pulmonary function test FEV1/FVC<70%,
FEV1<80% estimates, dispersion carbon monoxide lung volume -DLCO<40%, high resolution
CT showed a diffuse interstitial lung disease) disease activity and other researchers

7. on gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or
unable to tolerate oral medication, or active peptic ulcer;

8. any unstable system diseases: including active infection, uncontrolled hypertension,
unstable angina pectoris, within the last 3 months of the onset of angina, congestive
heart failure, the group in June before the myocardial infarction, need serious
mental disorder drug treatment, liver, kidney or metabolic diseases; mental /
spiritual diseases such as Alzheimer's disease;

9. without full control of ocular inflammation or eye infections, or any may cause the
eye disease situation;

10. known human immunodeficiency virus (HIV) infection;

11. with immunodeficiency disease, or suffer from other acquired, congenital
immunodeficiency disease, or a history of organ transplantation;

12. any disease, metabolic disorders, or physical examination or laboratory suspicion or
treatment of complications in patients at high risk of drug.
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