Prophylactic Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Patients With or Without Ovarian Metastasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This is a prospective phase III trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.
详细描述
A recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. The survival impact of oophorectomy has not been defined yet in this clinical setting. The incidence of microscopic ovarian metastasis has been reported to be approximately 10%. Therefore, the investigators propose a prospective study of oophorectomy followed by standard chemotherapy versus standard chemotherapy alone to determine whether oophorectomy increases survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed adenocarcinoma of colon
- •documented ovarian metastasis in CT or MRI or PET-CT
- •advanced (stage IV), metastatic, or recurrent
- •ECOG performance status of 0~2
- •adequate marrow, hepatic, renal and cardiac functions
- •no prior surgical treatment to ovary
- •provision of a signed written informed consent
排除标准
- •patient who refuses oophorectomy
- •medical condition in which surgery cannot be tolerated Any waiver of these inclusion and exclusion criteria must be approved by the investigator on a case-by case basis prior to enrolling the subject. This must be documented by the investigator. No subject will be allowed to enroll in this study more than once.
研究组 & 干预措施
Oophrectomy group
Patient undergone oophrectomy along with primary tumor
干预措施: Oophrectomy (Procedure)
without oophrectomy
Patient group without oophrectomy
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Disease free survival(3 years)
研究者
Won-Suk Lee
Assistant Prof
Gachon University Gil Medical Center