EUCTR2009-010390-21-DE进行中（未招募）不适用
A randomized, open-label, multi-center Phase II trial of bevacizumab and radiotherapy fol-lowed by bevacizumab and irinotecan vs. temozolomide and radiotherapy followed by temo-zolomide monotherapy in patients with newly diagnosed glioblastoma and a non-methylated MGMT-promoter (GLARIUS) - GLARIUS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Female and male patients with at least 18 years of age.
- •2.Patient provided signed informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and consent obtained prior to any study-specific procedure). This includes: willingness to give written informed consent, written consent for data protection (legal requirement in Germany: „datenschutzrecht-liche Einwilligung) and willingness to participate and to comply with the study.
- •3.Patients with newly diagnosed supratentorial Glioblastoma (GBM) confirmed histological (using WHO classification 2007) by complete resection, partial resection or open biopsy. This includes treatment-naïve-(chemotherapy and radiotherapy)-patients with prior diagnosis of a WHO grade II or III glioma that has progressed to a histological verified GBM.
- •4.Glioblastoma histology confirmed by reference neuropathology
- •5.Non-methylated MGMT promoter with cut off ratio < 0.6 in the tumor as determined by methylation-specific PCR (central MGMT assessment)
- •6.Craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization
- •7.Radiotherapy should be initiated = 22 days and = 35 days after surgery
- •8.Early postoperative (up to 72h) contrast-enhanced cranial MRI has been performed and is available for evaluation of resection status
- •9.Karnofsky score of 70% or higher
- •10.Stable or decreasing corticosteroids dose within 5 days prior to randomization
- •11.Adequate hematological function: white blood cell (WBC) count = 3x109/L, absolute neutrophil count (ANC) >1,5x109/L, platelet count = 100x109/L, hemoglobin = 8 g/dl (may be obtained by the use of erythropoietin or transfusion for anemia)
- •12.Adequate liver function: Total bilirubin < 1.5 x upper limit of normal (ULN) AND
- •aspartate aminotransferase (AST), alanine aminotransferase (ALT)< 2.5 x ULN
- •13. Adequate renal function: Serum creatinine = 1.5 x ULN AND patients with urine dip-stick for proteinuria < 2+. Patients with = 2+ proteinuria on dipstick urinalysis at baseline should show urine protein creatinine ratio = 1 or should undergo a 24 hour urine collection and must demonstrate = 1 g of protein in 24 hours
- •14.International normalized ratio (INR) (in absence of anticoagulation treatment) = 1.5 within 7 days prior to enrolment. Anticoagulation is allowed if target INR is < 3 and if the patient is on a stable dose of anticoagulant (coumarin type, low molecular weight heparin (LMWH) or bivalirudin or argatroban) for > 2 weeks at time of enrolment. Therefore, during the study, the preferred choice for anticoagulation treatment with therapeutic intent should be low molecular weight heparin as per ASCO guidelines.
- •15.Female patients should not be pregnant or breast-feeding. Women of child bearing potential (i.e., a woman who is biologically capable of becoming pregnant) must have a negative serum (ß-HCG) pregnancy test within 7 days prior to the first dose of study medication and radiotherapy. If a serum pregnancy test is not performed within 7 days prior to the first dose of bevacizumab, irinotecan, temozolomide and radiotherapy, a confirmatory urine test (within 7 days prior to the first dose of study medication and radiotherapy) is required. Patients (men and women) must agree to use medically accepted contraceptive methods with their partners throughout the study and for 6 months after the
排除标准
- •1. Histological confirmation by stereotactic biopsy
- •2. Evidence of recent hemorrhage on postoperative Gd-MRI of the brain. Patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, and presence of punctate hemorrhage in the tumor are permitted entry into the study
- •3. Subjects on any drug suspected to interfere with bevacizumab, irinotecan or temozolomide at randomization
- •4. Any prior chemotherapy for malignant glioblastomas and gliomas
- •5. Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential over-lap in the radiation field
- •6. Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment
- •7. Inadequately controlled hypertension (defined as a blood pressure of >150 mmHg systolic and/or >100 mmHg diastolic on medication) or any prior history of hypertensive crisis or hypertensive encephalopathy
- •8. History of stroke or transient ischemic attack within 6 months prior to enrolment
- •9. Significant vascular disease (e.g. aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to enrolment
- •10. Evidence or history of recurrent thromboembolism (>1 episode of deep venous thrombosis/peripheral embolism) during the past 2 years
- •11. Evidence of bleeding diathesis of coagulopathy (in the absence of therapeutic anticoagulation)
- •12. Chronic daily intake of aspirin >325 mg/day or clopridogel >75 mg /day
- •13. History of intracranial abscess within 6 months prior to randomization
- •14. History of abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment
- •15. History of = grade 2 hemoptysis according to NCI-CTC criteria within 1 month prior to randomization
- •16. Serious non-healing wound, ulcer or bone fracture
- •17. Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to planned first dose of bevacizumab administration
- •18. Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 7 days prior to planned first dose of bevacizumab administration.
- •Placement of a central vascular access device (CVAD) if performed within 2 days prior to bevacizumab administration
- •19. Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the 28 days (or five-half lives of the respective investigational product, whichever is longer) before enrolment
- •20. Patients who have participated in this trial before
- •21. Evidence for any active infection requiring hospitalization or i.v. antibiotics within 2 weeks prior to randomization
- •22. Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent
- •23. Patients with a history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study. If there is any reasonable doubt that the patient may not be able to provide consent, an independent psychiatrist or neurologist has to be consulted. If the psychiatrist or neurologist will provide a written statement that confirms the patient’s ability to provide consent the patient can sign the consent form and participate
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