Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The clinical response to neoadjuvant chemotherapy
研究概览
简要总结
Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.
However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.
This study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Untreated cervical cancer with FIGO stage Ib-IIb
- •Measurable lesions
- •Possible to radical hysterectomy
- •Age: 18 and older
- •Karnofsky Performance Status≥
- •WBC > 3,000/mm³, Hb > 9.0g/dl, Platelet > 100,000 /mm³, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG
- •Written informed consent
排除标准
- •Previous history of cancer
- •Patients with previous treatment
- •Patients without information of clinical risk factors
- •Patients who have active infection
结局指标
主要结局
The clinical response to neoadjuvant chemotherapy
时间窗: 1 to 3 months
clinical response（tumor size）
次要结局
- The pathological response to neoadjuvant chemotherapy(1 to 3 months)
研究者
Ding Ma
Director of Department of Gynecology and Obstetrics
Huazhong University of Science and Technology