EUCTR2011-001015-32-FR进行中（未招募）1 期
A prospective randomised Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer. - The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) Trial
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
- 796
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
- Female
入选标准
- •- Written informed consent and patients awareness
- •and willingness to comply with the study
- •requirements
- •- Primary diagnosis is confirmed by specialized
- •pathology review (Germany only)
- •- Age = 18 years
- •- Histologically confirmed, newly diagnosed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma and FIGO stage IIB - IV (all grades and all histological types)
- •- Patients should have already undergone surgical debulking and no planned surgical debulking prior to disease progression. Patients
- •with stage III and IV disease in whom initial surgical debulking was not
- •appropriate or possible are eligible providing other criteria are fulfilled
- •- Patients able to commence cytotoxic
- •chemotherapy within 8 weeks of cytoreductive surgery
- •- ECOG performance status 0-2
- •- Life expectancy > 3 months
- •- Adequate bone marrow function, coagulation parameters, liver function, postoperative glomerulare filtration rate (based on the Cockroft-Gault or Jelliffe formula)
- •- Urine dipstick for proteinuria < 2+. If
- •urine dipstick is = 2+, 24 hour urine must
- •demonstrate = 1 g of protein in 24 hours
- •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 796
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Non-epithelial origin of the ovary, the fallopian
- •tube or the peritoneum
- •- Borderline tumours and FIGO stage IA – IIA
- •- Planned intraperitoneal cytotoxic chemotherapy
- •- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
- •- Uncontrolled hypertension
- •- Any previous radiotherapy to the abdomen or pelvis
- •- Previous Cerebro-Vascular Accident, Transient Ischaemic Attack or Sub-Arachnoid Haemorrhage within 6 months prior to randomisation
- •- Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer and/or non-melanomatous skin cancer, carcinoma in situ of the breast and/or early endometrial carcinoma
- •- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless other criteria are fulfilled
- •- Non healing wound, active ulcer or bone fracture
- •- History or evidence of thrombotic or hemorrhagic disorders
- •- Clinically significant cardiovascular disease, including Myocardial infarction or unstable angina within 6 months of randomisation, NYHA = Grade 2, poorly controlled cardiac arrhythmia despite medication, Grade = 3 peripheral vascular disease
- •- Current or recent (within 10 days prior to randomisation) chronic use of aspirin > 325 mg/day
- •- Current or recent (within 10 days prior to randomisation) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes (except for line patency)
研究者
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