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临床试验/NCT01063296
NCT01063296Unknown不适用

Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites

研究概览

简要总结

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites

时间窗: 3 years

次要结局

  • Overall survival(3 years)

研究者

研究点 (1)

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