EUCTR2008-006146-26-ES进行中（未招募）1 期
Ensayo de fase III aleatorizado, doble ciego, controlado con placebo y multicéntrico de bevacizumab, temozolomida y radioterapia, seguidos de bevacizumab y temozolomida, en comparación con placebo, temozolomida y radioterapia seguidas de placebo y temozolomida en pacientes con un glioblastoma recién diagnosticado.A randomized, double blind, placebo controlled, multicenter Phase III trial of bevacizumab, temozolomide and radiotherapy, followed by bevacizumab and temozolomide versus placebo, temozolomide and radiotherapy followed by placebo and temozolomide in patients with newly diagnosed glioblastoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 920
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. Signed informed consent
- •2. Age greater than or equal to 18 years
- •3. Present with newly diagnosed supratentorial Glioblastoma (GBM) with a tissue
- •diagnosis that has been established following either a surgical resection or
- •biopsy. This includes treatment-naïve -(chemotherapy and radiotherapy)-
- •patients with prior diagnosis of a lower grade astrocytoma that has been
- •upgraded to a histologically verified GBM
- •4. 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 randomisation. Study treatment should be initiated ? 28 days and < 49
- •days following the last surgical procedure (including biopsy, surgical resection,
- •wound revision, or any other major surgery involving entry into a body cavity)
- •5. WHO performance status ? 2
- •6. Patient must have at least 1 formalin fixed paraffin embedded tumour tissue block
- •representative of glioblastoma available for pathology central review and analysis
- •of MGMT status. If tumour block is not available or not of adequate quality,
- •sufficient pathology material, representative of glioblastoma, must be available for
- •central review.
- •7. Stable or decreasing corticosteroids dose within 5 days prior to randomization
- •8. Adequate hematological function:
- •? Absolute neutrophil count (ANC) ? 1.5 x 1'000'000'000/L
- •? Platelet count ? 100 x 1'000'000'000/L
- •? Haemoglobin ? 10 g/dL (may be transfused to maintain or exceed this level)
- •9. Adequate liver function
- •? Total bilirubin ? 1.5 x ULN
- •? AST and ALT ? 2.5 x ULN
- •10. Adequate renal function
- •?Creatinine ? 1.25 x ULN
- •? Urine dipstick for proteinuria < 2+. Patients discovered to have ? 2+ proteinuria
- •on dipstick urinalysis at baseline should undergo a 24 hour urine collection and
- •must demonstrate ? 1.0 g of protein in 24 hours
- •? Urine protein/creatinine ratio (UPC) ? 1.0
- •11. International normalized ratio (INR) or PT (secs) and activated partial thromboplastin time (aPTT):
- •? 1.5 x ULN (except for subjects receiving anticoagulation therapy) in the absence
- •of therapeutic intent to anticoagulate the subject
- •? within therapeutic limits (according to the medical standard in the institution) in
- •the presence of therapeutic intent to anticoagulate the subject
- •NOTE: Use of full-dose anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks before randomization. As per ASCO guidelines, LMWH should be the preferred approach
- •12. Willing and able to comply with the protocol as judged by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease and Treatment History
- •1. Evidence of recent hemorrhage on postoperative MRI of the brain. However,
- •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
- •2. Previous centralized screening for MGMT status for enrolment into a clinical trial
- •3. Any prior chemotherapy (including carmustine-containing wafers (Gliadel®) or
- •immunotherapy (including vaccine therapy) for glioblastomas and low
- •grade astrocytomas
- •NOTE: 5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) administered prior to surgery to aid in optimal surgical resection is not considered
- •a chemotherapy agent
- •4. Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential
- •overlap in the radiation field
- •Bevacizumab related Exclusion Criteria
- •5. Inadequately controlled hypertension (defined as systolic blood pressure >150
- •mmHg and/or diastolic blood pressure >100 m Hg)
- •6. Prior history of hypertensive crisis or hypertensive encephalopathy
- •7. New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •(see Appendix 6)
- •8. History of myocardial infarction or unstable angina within 6 months prior to
- •randomization
- •9. History of stroke or TIAs within 6 months prior to randomization
- •10.Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or
- •recent peripheral arterial thrombosis) within 6 months prior to randomization
- •11.History of ? grade 2 haemoptysis according to the NCI-CTC criteria within 1
- •month prior to randomization
- •12.Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic
- •anticoagulation)
- •13.Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal
- •shunt or significant traumatic injury within 28 days prior to randomization
- •14.Core biopsy (excluding intracranial biopsy) or other minor surgical procedure
- •within 7 days prior to randomization. Placement of a central vascular access
- •device (CVAD) if performed within 2 days prior to bevacizumab/placebo administration
- •15.History of abdominal fistula or gastrointestinal perforation within 6 months prior
- •to randomization
- •16.History of intracranial abscess within 6 months prior to randomization
- •17.Serious non-healing wound, active ulcer or untreated bone fracture
- •18.Pregnant or lactating females. NOTE: Serum pregnancy test to be assessed within 7 days prior to study treatment start
- •19.Fertile women < 2 years after last menstruation and men (surgically sterilized
- •and of childbearing potential) unwilling or unable to use effective means of
- •contraception (oral contraceptives, intrauterine contraceptive device, barrier
- •method of contraception in conjunction with spermicidal jelly)
- •General Exclusion Criteria
- •20.Any previous malignancy which was treated with curative intent within 5 years
- •prior to randomization, except for adequately controlled limited basal cell
- •carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the
- •21.Evidence of any active infection requiring hospitalization or IV antibiotics within 2
- •weeks prior to randomization
- •22.Patients who have any other disease, either metabolic or psychological, or who
- •have any evidence on clinical examination or special investigations (inclu
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