For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
464
Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Yulin First Hospital
Yulin, Guangxi, China
Progression-free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Objective response rate
Time frame: 3 years
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