Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amsterdam UMC, location VUmc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological or cytological confirmation of non-small cell lung cancer (NSCLC)
Diagnosis of brain metastases on a contrast-enhanced CT scan or Gadolinium-enhanced MRI
Patients who are not candidates for surgery or stereotactic radiosurgery
RPA Class 1 or 2 (Karnofsky performance status \> 70)
Age \> 18 years
No previous radiotherapy, surgery or chemotherapy for brain metastases
Patients must be able to take oral medication.
Patients should not have any unstable systemic disease except lung cancer (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
Granulocyte count \> 1.5 x 109/L and platelet count \> 100 x 109/L OK
Serum bilirubin must be \< 1.5 upper limit of normal (ULN).
AST and/or ALT \< 2 x ULN (or \< 5 x ULN if clearly attributable to liver metastasis)
Patients with reproductive potential must use effective contraception. For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
Able to comply with study and follow-up procedures
Written informed consent.
You may not be if
Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
Signs, symptoms or MRI findings consistent with leptomeningeal metastases.
Concomitant use of phenytoin anticonvulsant medication
Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
Any other malignancies in the preceding 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Any significant ophthalmological abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and ophthalmologist.
Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
