Glioblastoma
Conditions
Interventions
Trial group:Temozolomide-based concurrent chemoradiotherapy followed by adjuvant temozolomide (Stupp protocol):
Concurrent chemoradiotherapy phase: Oral temozolomide 75 mg/m^2/day for 42 days, along
Control Group:Standard Stupp protocol with concurrent oral sitagliptin phosphate tablets 100 mg:
Concurrent chemoradiation phase: Take sitagliptin 100 mg 2–3 hours before radiotherapy.
Maintenance
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Chemoradiotherapy is planned to begin within 6 weeks after tumor resection. A total radiation dose of 54–60 Gy (RT) is administered, along with concurrent TMZ chemotherapy [75 mg/m^2, with actual dosage within the range of 75 mg/m^2 +/- (75 mg/m^2 × 10%)]. 2. Adjuvant TMZ chemotherapy is planned at a dose of 150–200 mg/(m^2·d) [actual dosage within the range of 150–200 mg/m^2 +/- (150–200 mg/m^2 × 10%)], administered daily for 5 consecutive days followed by 23 days off, with a 28-day cycle, for a total of 6 cycles. 3. The subject has a Karnofsky performance score >=60. 4. The subject has an estimated survival time >=3 months. 5. Subjects of childbearing potential must agree to use effective contraception during the trial. 6. The subject agrees to participate in the trial and has signed the informed consent form. 7. Corticosteroid therapy dosage has been stable or reduced within 7 days prior to randomization.
Exclusion criteria
Exclusion criteria: 1. The subject received any other cytotoxic or biological anti-tumor therapy prior to enrollment. 2. The subject is concurrently participating in another clinical trial or is a pregnant or lactating female. 3. Prior to enrollment, the subject’s bone marrow and liver/kidney function must meet certain criteria; any of the following conditions excludes eligibility: (1) Thrombocytopenia (platelet count 3 times the upper limit of normal); (5) Total bilirubin > 1.5 times the upper limit of normal; (6) Severe renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/L). 4. Confirmed increased intracranial pressure (clinically manifested by severe papilledema, vomiting, nausea, or decreased consciousness). 5. Known allergy to TMZ and sitagliptin. 6. Type I diabetic patients. 7. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactMeng Qingming
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed