ISRCTN91273375已完成3 期
A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer
Medical Research Council (UK)0 个研究点目标入组 1,520 人开始时间: 2006年1月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,520
研究概览
简要总结
- 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22204725 2. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26115797 3. 2016 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/27325335 4. 2019 exploratory outcome results in: https://www.ncbi.nlm.nih.gov/pubmed/30449719 (added 05/02/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Written informed consent and able to comply with the protocol
- •2. Histologically confirmed:
- •2.1. High risk International Federation of Gynaecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancer
- •2.2. FIGO stage IIb - IV (all grades, all histological types) epithelial ovarian cancer
- •2.3. Fallopian tube or primary peritoneal cancer
- •3. Patients fit enough to receive protocol treatment
- •4. Urine dipstick for proteinuria less than 2+ (if urine dipstick is greater than or equal to 2+, 24 hour urine must demonstrate less than or equal to 1 g of protein)
排除标准
- •1. Surgery (including open biopsy), or radiotherapy within the last 4 weeks prior to first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
- •2. 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
- •3. Uncontrolled hypertension
- •4. Current or recent (within 10 days of first dose of study treatment) use of aspirin greater than 325 mg/day
- •5. Current or recent (within 10 days prior to study treatment start) 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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