NCT00592059Unknown不适用
A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 77
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.
详细描述
Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
- •Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
- •above 20 years
- •GOG performance status 0-2
- •Informed consent
- •Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit, bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit
- •Expected life > 6 months
排除标准
- •Peripheral neurotoxicity > NCI grade 2
- •Sever infection
- •Previous history with chemotherapy or radiation therapy
- •Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI grade 2
- •Paraaortic lymph node metastasis
- •Allergy with platinum
- •Previous history of atrial or ventricular arrhythmia or congestive heart failure
- •Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
- •Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade
研究者
研究点 (1)
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