The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .
Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
PFS
Progression-Free Survival
Time frame: from enrollment to progression or death (for any reason),assessed up to 18months
OS
Overall Survival
Time frame: from enrollment to death (for any reason).assessed up to 24 months
adverse event
Adverse events are described in terms of CTC AE 5.0
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Health-related quality of life
Health-related quality of life are measured by the EORTC-QL30/BN20.
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Neurocognitive function
Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).
Time frame: from enrollment to death (for any reason).assessed up to 24 months
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Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.