All patients will be randomized to receive WBRT or Erlotinib concurrent WBRT. Erlotinib
concurrent WBRT, patients were given a loading dose of erlotinib 150mg per day for 6 days,
after which all patients received erlotinib 150mg per day concurrently with WBRT. Dose
reduction was allowed for intolerable adverse effects (grade ≥3) such as rash or diarrhea in
50 mg increments down from 150mg to 100 mg and then to 50 mg if needed. Radiation therapy
was delivered in 2.0 Gy fractions once per day 5 days per week to a total dose of 40Gy (20
fractions). Radiation was delivered as opposed lateral 8-MV beams with a Sweden precise
linear accelerator.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to neurologic progression
A) assess the local control of brain metastases status (including: the proportion of salvage therapy, the proportion of radiation necrosis lesions) B) evaluation of intracranial metastasis status (at the site of the primary tumor than the emergence of new brain metastases)
13 months
Yes
China: Food and Drug Administration
Yang-1970
NCT01887795
August 2013
August 2016
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