ACTRN12607000188437进行中（未招募）3 期
A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer to assess progression-free survival benefits
Medical Research Council (UK)0 个研究点目标入组 1,520 人开始时间: 2007年3月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,520
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Written informed consent and able to comply with the protocol2. Histologically confirmed:a. High risk International Federation of Gynecology and Obstetrics (FIGO) stage I and II a, with grade 3 or clear cell histology, epithelial ovarian cancerb. FIGO stage IIb–IV (all grades, all histological types) epithelial ovarian cancerc. Fallopian tube or primary peritoneal cancer3. Patients fit enough to receive protocol treatment4. Urine dipstick for proteinuria <2+ (if urine dipstick is > or = 2+, 24 hour urine must demonstrate < or = 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 treatment2. 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 cancer3. Uncontrolled hypertension4. Current or recent (within 10 days of first dose of study treatment) use of aspirin >325 mg/day5. 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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A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancerEpithelial ovarian cancerCancerOvarian cancerISRCTN91273375Medical Research Council (UK)1,520
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ICON7 - A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer. - ICON7 GCIG Trial (International Collaborative Ovarian Neoplasm 7)EUCTR2005-003929-22-DEMedical Research Council1,520
进行中（未招募）
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ICON7 - A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer.Following initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease and there is no planned surgery before disease progression) patients with newly diagnosed FIGO stage I or IIa (Grade 3 or clear cell histology only), or FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, in whom no further surgery prior to disease progression is plannedMedDRA version: 8.1Level: LLTClassification code 10033128Term: Ovarian cancerEUCTR2005-003929-22-GBMedical Research Council