MGMT-Unmethylated Glioblastoma
Conditions
Brief summary
The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.
Detailed description
For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).
Interventions
DRUGAnlotinib
Anlotinib With STUPP Regimen
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-70 years, 2. Histologically proven diagnosis of glioblastoma (WHO grade IV), 3. Have received standard STUPP treatment plan, 4. Gross resection or partial resection of the tumor (confirmed by MRI)\> 50%, 5. The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60, 6. No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L 8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 10.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 11.Able to provide written informed consent
Exclusion criteria
1. Recurrent or multiple malignant gliomas 2. Subtentorial glioblastoma or metastatic lesions outside the skull 3. Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery 4. Previously received radiation therapy for the head and neck cancer 5. Have received any antibody treatment before 6. Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection，Unstable angina and/or congestive heart failure within the last 6 months，co-morbidity with immunosuppressive therapy 7. Evidence of bleeding diathesis or coagulopathy 8. Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year OS | from enrollment to death (for any reason).assessed up to 12 months | 1-year overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| PFS | from enrollment to progression or death (for any reason),assessed up to 24months | Progression-Free Survival |
| 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 |
Countries
China
Outcome results
None listed