Grade IV glioma
Conditions
Interventions
Experimental group:radiotherapy+temozolomide+fluoxetine
Sponsors
Department of Radiotherapy in Dongguan People’s Hospital
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients newly diagnosed with WHO Grade IV glioma (including IDH-mutant astrocytoma grade IV, glioblastoma, diffuse astrocytoma, and diffuse midline glioma) after surgery pathology or biopsy, and have not received radiotherapy or chemotherapy; (2) Aged between 25 and 70 years; (3) Karnofsky Performance Status (KPS) score = 70; (4) Major organ function meets the following criteria (no use of any blood components or growth factors within 14 days): a. Absolute Neutrophil Count (ANC) = 1.5×10^9 /L; Platelet Count (PLT) = 100×10^9 /L; Hemoglobin (HB) = 90 g/L; b. Total bilirubin = 1.5× Upper Limit of Normal (ULN); c. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) = 3 × ULN; d. Serum creatinine = 1.5× ULN, or creatinine clearance rate = 50 mL/min (calculated according to the Cockcroft-Gault formula); (5) Life expectancy = 12 weeks; (6) Stable or decreasing dose of corticosteroids taken in the 14 days prior to enrollment. (7) Subjects voluntarily participate in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) History of allergy to any drug or component of fluoxetine or temozolomide; (2) History of other malignant tumors within the past 5 years or concurrent malignancy, or previous receipt of any anti-tumor treatment; (3) Subjects participating in another clinical trial, except for observational studies; (4) Significant comorbidities that may interfere with temozolomide or fluoxetine treatment a. Grade 4 non-hematologic toxicity, excluding alopecia, nausea, and vomiting (CTCAE 5.0) b. Diseases that interfere with oral medication, including dysphagia, chronic diarrhea, or intestinal obstruction; (5) Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting, nausea, or decreased level of consciousness); (6) Known history of abuse of psychiatric drugs, alcoholism, or drug abuse; (7) Pregnant or lactating women; (8) Other conditions that, in the investigator's judgment, may affect the safety or compliance of the subjects, including but not limited to unstable heart disease, kidney disease, poorly controlled diabetes, emotional disorders, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Safety;Quality of life score;Cognitive function; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Department of Radiotherapy, Affiliated Dongguan People’s Hospital, Southern Medical University, (Dongguan People’s Hospital), 78 xinguchong Wandao Road South,Dongguan, Guangdong
Outcome results
None listed