NCT04716257招募中不适用
Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Ovarian specific overall survival
研究概览
简要总结
This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.
详细描述
This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.
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
- •Histologically confirmed colorectal adenocarcinoma;
- •Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
- •Women ≥18 years of age;
- •Eastern Cooperative Oncology Group performance status score ≤2;
- •Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
- •Complete medical records;
- •Informed consent form signed.
排除标准
- •Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
- •Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
- •Other conditions that would influence patient compliance;
- •Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.
结局指标
主要结局
Ovarian specific overall survival
时间窗: up to 3 years
Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time.
次要结局
- Ovarian specific objective response rate(6 months)
- Quality of life questionnaire(6 months)
- Extra-ovarian specific objective response rate(6 months)
- Progression free survival(6 months)
研究者
研究点 (4)
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