glioma
Conditions
Interventions
Temozolomide group:Population pharmacokinetic monitoring
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 18 to 75 years with newly diagnosed glioma (WHO classification: II-IV) and a clear histological diagnosis. (2) At least one tissue block can be obtained during surgery for MGMT analysis. (3) Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. (4) Simultaneous radiotherapy treatment with temozolomide for glioma is expected to be started at week 5 (day 29 ± 14) after surgery. (5) Postoperative wound healing was good and stitches were removed. (6) Neutrophil count =1.5×109/L and platelet count =100×109/L. (7) Serum creatinine clearance in the range of 36-130 ml/min. (8) Mild-moderate hepatic insufficiency (Child pugh grade A or B) (9) Voluntary signed informed consent. (10) Patients of childbearing age (including female and male patient's female partner) must be using effective birth control measures. (11) Patients who are not undergoing other clinical trials.
Exclusion criteria
Exclusion criteria: (1) Have a previous malignancy at another site with onset < 3 years. (2) Use of radiation, chemotherapy or other antineoplastic agents for the study indication prior to enrollment in this clinical trial. (3) Postoperative wounds have not healed. (4) Recurrent or multiple malignant gliomas (including gliomatous encephalopathy). (5) Glioma in the brainstem site. (6) Frequent vomiting or presence of conditions that interfere with oral administration of medications (e.g., uncontrolled CTCAE grade II or higher after standard antiemetic therapy). (7) HIV-positive or with AIDS-related disease. (8) Pregnant or lactating women. (9) Known hypersensitivity to temozolomide or other similar alkylating agents. (10) Any other condition that the investigator deems inappropriate for enrollment in the study, such as known poor compliance of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Population pharmacokinetic model; | — |
Countries
China
Contacts
Public ContactJunyan Wu, Xin Mei
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed