EUCTR2019-002474-30-IT进行中（未招募）1 期
PERSONALIZED MOLECULAR DRIVEN SURGERY ACCORDING TO BRCA MUTATIONAL STATUS IN ADVANCED EPITHELIAL OVARIAN CANCER PATIENTS WITH HIGH TUMOR LOAD - NIRAMUN/NOM
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 210 人开始时间: 2021年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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
- •1. Diagnosis of advanced epithelial ovarian cancer (FIGO stage III B-IV)
- •2. high tumor load assessed by laparoscopy according to the Fagotti’s score (PIV 8-12)
- •3. age between 18 and 80
- •4. Performance Status (ECOG) = 2, an adequate respiratory, hepatic, cardiac, bone marrow, liver and renal function (Creatinine Clearance > 60 mL/min according to Cockroft formula)
- •5. sBRCA-wt
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. FIGO stages IA-IIIA ii
- •2. any histology but high grade serous
- •3. hepatic dysfunction defined as a Model for End-Stage Liver Disease score of 10 or greater, renal dysfunction defined as serum creatinine of 2.0 mg/dL or greater
- •4. history of any type of cancer in the past 5 years
- •5. concomitant other malignancies
- •6. pregnancy or lactation
- •7. refusal to provide written informed consent.
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