A Single-Centre Prospective Phase 0 Translational Study for Predicting Response of High Grade Serous Ovarian Cancers to Paclitaxel Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment
研究概览
简要总结
The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.
详细描述
While paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment. As with any chemotherapy, paclitaxel is associated with unpleasant side effects. We are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment. We hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment. We also want to understand why some cancer cells don't get killed with paclitaxel. This information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Female ≥ 18 years of age
- •Newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma.
- •Radiological and laparoscopic confirmation of FIGO stage 3C or 4 ovarian cancer.
- •Radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy.
- •At least one lesion on CT scan measuring at least 2 cm in maximum diameter performed in the past 31 days. Slightly older scans may be accepted at the discretion of the CI providing the results are considered to remain clinically relevant.
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
- •Life expectancy of at least 6 months.
- •The patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations.
- •Acceptable haematological and biochemical indices
排除标准
- 未提供
结局指标
主要结局
Correlation between βIII tubulin expression and Mitotic Index (MI) following single agent paclitaxel treatment
时间窗: Before and 24-hours after paclitaxel treatment
Correlation between βIII tubulin expression and Mitotic Index (MI) before and after single agent paclitaxel treatment to determine whether overexpression of βIII tubulin is associated with Paclitaxel resistance
次要结局
- Correlation between mitotic index and the magnitude of CA125 response(three weeks after paclitaxel treatment)