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.]

NCT01763385 : Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: 85 Years
Eligibility
Inclusion Criteria:

1. Over the age of 18 years old;

2. Tissue or cell pathological diagnosis of NSCLC;

3. Brain CT or MR validated BM;

4. Non-increased-intracranial-pressure symptomatic BM;

5. Haven't received TKI target treatment;

6. Haven't received brain radiotherapy;

7. Patients in initial treatment should be detected EGFR mutation;

8. Expected survival more than 6 months;

9. KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain
metastases;

10. Liver and kidney function requirements: SGOT/SGPT?2.5 times of the upper limit, Total
bilirubin?1.5 times of the upper limit, serum Creatinine?1.5 times of the upper
limit;

11. Routine blood test requirements: WBC?3.0×109/L, NE?1.8×109/L, PLT?90×109/L?no
requirement for Hb;

12. Blood glucose requirements: within the normal range, diabetic patients are receiving
treatment and their glucose was being controlled in a steady state;

13. Female patients in childbearing age: HCG (-);

14. Patients signed an inform Consent.

Exclusion Criteria:

1. Those with Erlotinib drug allergies;

2. Those with mathematical understanding of the most simple life questions, such as
"walking", those difficult for doctors to communicate;

3. Those without guardians or families;

4. Those with abnormal routine blood test, liver and kidney function, and blood glucose
beyond the above boundaries and difficult to correcting for more than 2 weeks;

5. Those with any unstable medical status (including active infection, uncontrolled
hypertension, unstable angina, congestive heart failure, myocardial infarction
(within one year before treatment initiation), and severe arrhythmia, liver, kidney
or metabolic disease requiring drug therapy);

6. Those with any other disease, neurological or metabolic dysfunction, and physical
examination or laboratory test results showed that the study drugs may increase the
risk of treatment-related complications;

7. Pregnant women.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01763385      |      Link to official Clinicaltrials.gov listing
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