Glioblastoma
Conditions
Brief summary
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
Interventions
DRUGDrug is Anlotinib.
Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .
DRUGDrug is Temozolomide Capsule.
Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .
RADIATIONRadiotherapy was initiated 4 to 6 weeks postoperatively.
Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR); 2. 2 \ 6 weeks after operation; the surgical incision healed well; 3. Presence of lesions evaluable according to Rano criteria; 4. Aged 18-70 years; 5. Karnofsky performance status (KPS) ≥ 60; 6. The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days; 7. No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy; 8. Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L; 9. Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min; 10. Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN; 11. Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s); 12. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration; 13. Patient is sufficiently compliant with study and follow-up procedures; 14. Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.
Exclusion criteria
1. Secondary glioblastoma; 2. Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ; 3. Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy); 4. Pregnant or lactating women; 5. Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures; 6. Evidence of hereditary bleeding constitution or coagulation disorders; 7. Patients requiring anticoagulant therapy due to other diseases;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from enrollment to progression or death (for any reason),assessed up to 18months | Progression-Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | from enrollment to death (for any reason).assessed up to 24 months | Overall Survival |
| adverse event | from enrollment to death (for any reason).assessed up to 24 months | Adverse events are described in terms of CTC AE 5.0 |
| Health-related quality of life | from enrollment to death (for any reason).assessed up to 24 months | Health-related quality of life are measured by the EORTC-QL30/BN20. |
| Neurocognitive function | from enrollment to death (for any reason).assessed up to 24 months | Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE). |
Countries
China
Outcome results
None listed