Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients
Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery
Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors .
In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Hubei
-
Wuhan、Hubei、中国
- Tongji Hospital of HUST
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with histologically confirmed Ib~IIa (FIGO)cervical carcinoma without previous treatments
- Age between 18-70
- With the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm
- At least 3 months of disease-free survival
Exclusion Criteria:
- The presence of other uncontrolled life-threatening disease (Suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis)
- Receiving other anti-cancer therapy, such as traditional Chinese drug
- Don't be able to finish the whole treatment(chemotherapy or radiotherapy)
- liver dysfunction (ALT、AST>2.5×ULN)
- renal dysfunction (Creatinine>1.5×ULN)
- WBC<4,000/mm3 or PLT<100,000/mm3
- Received preoperative radiotherapy
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites
大体时间:3 years
|
3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
总生存期
大体时间:3年
|
3年
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.