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临床试验/NCT03611179
NCT03611179Unknown2 期

Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer

Nada Hassan Salah0 个研究点目标入组 40 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
40
主要终点
progression free survival

研究概览

简要总结

Our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.

详细描述

Ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer death in women .The majority of women with ovarian cancer are diagnosed with advanced-stage disease; only 15% of all cases are diagnosed with local disease. Risk factors for ovarian cancer include family history, nulliparity, lack of breast feeding, and infertility .

The GOG-0218 trial demonstrated that the use of bevacizumab in the front-line and maintenance setting improved progression free survival by 3.8 months when compared with conventional every-3-weeks carboplatin and paclitaxel.

The ICON-7 trial also aimed to compare the progression free survival and Overall survival in women who receive bevacizumab with carboplatin/paclitaxel and women receiving carboplatin/paclitaxel alone The final results of ICON7 were announced in 2013. Overall, the results showed no difference in overall survival between those in the group receiving bevacizumab han those in the group receiving no bevacizumab. However, for high-risk patients, who were most likely to have early disease progression, the results were positive and showed an improvement in overall survival of 4.8 months in the group who received bevacizumab.

Not only has the best route been intensely debated but the optimal timing of therapy has been and is currently being studied. Chemotherapy is usually given either only after primary debulking surgery or as both neoadjuvant chemotherapy before and after interval debulking surgery. recent trials have tried to determine which treatment timing is associated with better outcomes .

The aim of the study will be assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients diagnosed with advanced ovarian cancer by biopsy
  • Age more than 18 years old
  • Routine labs are within normal values ( CBC, renal function tests , liver function tests )
  • Performance score 0-2
  • FIGO stage II-IV
  • Not having any contraindication to bevacizumab as : uncontrolled hypertension , bleeding tendency , ischaemic events
  • Chemotherapy naïve.
  • Informed consent

排除标准

  • patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis
  • patients with uncontrolled infection
  • patients with clinically significant cardiovascular disease
  • patients with active bleeding or conditions associated with high risk of bleeding
  • patients with history of CNS disease

研究组 & 干预措施

advanced ovarian cancer cases

Experimental

patients with advanced ovarian cancer will receive Bevacizumab 15 mg/kg every 21 days with chemotherapy (Paclitaxel 175 mg/m2 & Carboplatin AUC 5 every 21 days)

干预措施: Bevacizumab (Drug)

结局指标

主要结局

progression free survival

时间窗: 2 years

determination of time from starting treatment until first progression

次要结局

未报告次要终点

研究者

发起方
Nada Hassan Salah
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nada Hassan Salah

principal investigator

Assiut University

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