Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm Experimental: arm Biological: Anlotinib Drug: Temozolomide Radiotherapy:2.0 Gy/fraction ×30 fractions Monday to Friday total dose of 60Gy |
Biological: Anlotinib
Anlotinib With STUPP Regimen
Drug: Temozolomide Capsule
Anlotinib With STUPP Regimen
|
Outcome Measures
Primary Outcome Measures
- PFS [from enrollment to progression or death (for any reason),assessed up to 18months]
Progression-Free Survival
Secondary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
1.Histologically proven diagnosis of glioblastoma (WHO grade IV) 2.1.4-6 weeks after surgery and incision has healed 3.Patients with quantifiable target lesions according to RANO criteria 4.Aged 18-70 years 5.Karnofsky performance status ≥ 60 6.Corticosteroids doses has been stabilized or decreased within 5 days 7.No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 8.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L 9.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 10.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 11.Adequate coagulation function: PT ≤ 5 seconds above the UNL， APTT≤ 5 seconds above the UNL 12.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 13.Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up 14.Able to provide written informed consent
Exclusion Criteria:
-
Recurrent malignant gliomas
-
Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)
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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
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Pregnant or lactating women
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women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
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Evidence of bleeding diathesis or coagulopathy
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Patients on anticoagulants for co-morbidity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang cancer hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
- Principal Investigator: Chen Ming, Zhejiang Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GBM-AS