A randomized open-label phase 2 study to evaluate the efficacy between only radiotherapy versus combination therapy with radiotherapy and temozolomide

Asan Medical Center0 个研究点目标入组 104 人开始时间: 待定最近更新: 2019年3月11日

研究概览

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•1) Histologically confirmed newly diagnosed anaplastic gliomas of WHO grade III, including anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma
•2) Chromosome 1p/19q NOT co-deleted
•3) Age of = 19 years and = 70 years
•4) ECOG performance scale 0 -2
•5) Stable or decremental dosage of steroid use for 14 days before registration or 5 days before randomization
•6) No problems with CBC, blood chemistry includings liver function and renal function
•- Blood cells
•- neutrophils =1.5 x 109/L
•- platelets =100 x 109/L
•- Liver function test
•- Total bilirubin =1.5 x normal upper limit
•- AST, ALT =2.5 x normal upper limit
•- Alkaline phosphatase =2.5 x normal upper limit
•- Renal function test
•- Creatinine clearance =60 mL/min, serum creatinine =1.5 mg/dL
•7) Patients with written informed consent

•1) History of prior chemotherapy or radiotherapy
•2) Pregnant or lactating women
•3) Subject who disagree to follow acceptable methods of contraception
•4) History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study
•5) Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization
•6) Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection

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