A Multicentre, Observational Study of Bevacizumab (Avastin) Added to Front-line Chemotherapy in Patients With Stage IIIb, IIIC or IV Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma in Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma
详细描述
In the last decade, clinical studies with bevacizumab (Avastin) in various tumors have shown encouraging results in terms of efficacy/safety. However there is no data generated in Greek population with regards to safety and efficacy of bevacizumab in front line Ovarian Cancer. Two prior global phase III randomized trials showed that the addition of concurrent bevacizumab to standard chemotherapy and maintenance bevacizumab significantly increased the PFS in patients with advanced ovarian cancer It would be relevant to document the real life clinical data of bevacizumab in combination with chemotherapy (paclitaxel/carboplatin) in Front Line Ovarian Cancer as prescribed by the medical oncologists in Greece.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥18 years
- •Histologically confirmed advanced stage III (suboptimally debulked >1cm of residual disease) or stage IV ovarian cancer fallopian tube carcinoma or primary peritoneal cancer following surgical debulking with the aim of maximal surgical cytoreduction
- •One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
- •ECOG performance status ≤2
- •Adequate haematological, renal and hepatic function
- •Urine protein <2+ (dipstick)
- •Life expectancy of >12 weeks
排除标准
- •Previous front line treatment for ovarina cancer
- •Previous radiotherapy to target lesions
- •Patients with brain metastases and/or cancerous meningitis
- •Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
- •Patients participating in interventional clinical trial
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Every 3 weeks up to 18 weeks
In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks
次要结局
- Percentage of Patients with Progression Free Survival(1 year)
- Number of Participants with Response Rate(Disease evaluation at Week 3)
- Patients Overall Survival(1 year)