BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Objective response rate.
研究概览
简要总结
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.
详细描述
Ovarian cancer was the third most common gynecological cancer globally in 2020. Ovarian carcinoma is the most common type of ovarian cancer, comprising over 90% of all ovarian cancer cases.
It is the most lethal gynecologic malignancy in high-income countries.
Approximately, 10-15% of epithelial ovarian cancer (EOC) patients carry germline mutation in BRCA1 or BRCA2. But,the majority of cases are sporadic.
Increased body mass index (BMI) and hormone replacement therapy (HRT) have been proposed as major contributors along with smoking and occupational hazards e.g., asbestos exposure.
Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca ( EOC) subtypes, with prevalence of 20%-25% reported for the high-grade serous subtype , BRCA mutations were reported in <10% of the endometrioid subtype and with very low frequency in clear cell subtype (6.3%).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years,
- •Pathologically proven ovarian cancer,epithelial origin.
- •BRCA mutant/wild
- •Recurrent cases who are eligible to anti-VEGF (Bevacizumab).
- •Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases.
- •Patients with good renal and liver functions.
- •No other malignancy (double malignancy).
- •Performance status 0-2 according to ECOG performance status scale.
排除标准
- •Performance status 3-4 according to ECOG performance status scale.
- •Patients refuse to receive chemotherapy,
- •Patients not eligible to receive chemotherapy due to liver or renal impairment.
结局指标
主要结局
Objective response rate.
时间窗: 1 year
percentage of people in the study or treatment group who have a partial response or complete response to the treatment within a certain period of time; wil be correlated with BRCA status.
Progression free survival
时间窗: 1 year
the time from starting the study till disease progression or death from any cause
次要结局
- Overall survival and toxicity(2 years)
研究者
Nesreen Haidra Ahmed Garad
Principal investigator
Assiut University