The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same time as WBRT with giving the drug after WBRT is complete.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Feldkirch Regional Hospital
Feldkirch, Austria
Graz Medical University
Graz, Austria
Univeristy Clinic for Radiotherapy and Radio-Oncology
Innsbruck, Austria
Klagenfurt Regional Hospital
Klagenfurt, Austria
University Internal Medicine Clinic III
Salzburg, Austria
Kaiser-Franz-Josef-Spital
Vienna, Austria
Unnamed facility
Heidelbert, Germany
To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Overall response rate (ORR)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Progression free survival (PFS)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Time to neurologial progression (TNP)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Overall survival (OS)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
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