Central nervous system glioma
Conditions
Interventions
Group1:T-R
Group2:R-T
Sponsors
The First Hosipital of Jlin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) To be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) Male and female subjects aged 18 to 65 years (including 18 and 65 years); 5) Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18 to 28 (including the critical value); 6) Patients diagnosed with pleomorphic glioblastoma or anaplastic astrocytoma by imaging and pathology, or patients who are receiving temozolomide or who are receiving temozolomide; 7) Patients who are not currently using steroid hormone therapy if the patient has been using a steroid test before taking a dose at least one stable steroid dose for the next week; 8) If the patient has received radiotherapy, should be at least 14 days between the last day of radiotherapy and the first day of the trial; 9) ECOG physical status score of 0 or 1; 10) Expected to live longer than 3 months; 11) Have appropriate blood system function (neutrophil absolute value (ANC) =1.2×10^9/L (no growth factor therapy), white blood cell (WBC) =3.0×10^9/L, platelet (PLT) =75×10^9/L, hemoglobin (Hb) =90 g/L (no need for transfusion support therapy or growth factor therapy)), liver function (ALT and AST <1.5-fold upper) and renal function; 12) Creatinine clearance rate =60mL/min, creatinine clearance using Cockcroft-Gault formula: male (140-year)×body weight (kg)/[0.818×serum creatinine (umol/L)], women calculated by the results×0.85.
Exclusion criteria
Exclusion criteria: 1) Have a history of allergies the test drug or its accessories , allergy (a variety of drugs and food allergy); 2) Have a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine); 3) A large number of blood loss (> 450 mL) within three months before taking the study drug; 4) Have the central nervous system, cardiovascular system, liver and kidney dysfunction, blood system or any other disease may affect the results of the disease; 5) Drugs can not control epilepsy patients; 6) Have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs; 7) Taking any drug that changes liver enzyme activity 28 days before taking the study drug; 8) Taking drugs and any vitamins or herbs that affect the pharmacokinetics of temozolomide within 14 days of taking the study drug; 9) Combined with drugs that affect pharmacokinetics of temozolomide, such as valproic acid; 10) Patients who had previously received nitrosourea alkylating agents for severe vomiting; 11) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 12) Participated in drug clinical trials within three months prior to taking the study; 13) Have special requirements for diet, can not comply with the unified diet arrangements; 14) The investigator considers that any other circumstances that may affect the subject's consent or compliance with the test program or any circumstances in which they are unfit to participate in the trial; 15) ECG abnormalities have clinical significance; 16) HIV antigen / antibody positive, hepatitis B surface antigen positive or hepatitis C antibody positive, Treponema pallidum positive; 17) Have difficulty in blood collection; 18) Pregnancy test positive or in lactating female subjects; 19) In the pre-study screening stage or before the study of acute disease; 20) Ingested chocolate, any caffeine, or xanthine-containing food or drink 48 hours before taking the study drug; 21) Taking any alcoholic products within 24 hours prior to taking the study; 22) Alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The prototype object; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hosipital of Jlin University
Outcome results
None listed