NCT00193271已完成2 期
Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Response Rate
研究概览
简要总结
This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.
详细描述
Upon determination of eligibility, patients will receive:
Docetaxel + Estramustine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •To be included in this study, you must meet the following criteria:
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinically or surgically staged localized disease, stage I-III.
- •Prior surgical resection or radiation therapy with curative intent
- •No clinical evidence of residual disease
- •Gleason's combined score >
- •Age > 18 years.
- •No prior chemotherapy for prostate cancer.
- •No previous androgen deprivation therapy for prostate cancer
- •Able to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •Voluntarily provide written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •History of prior malignancy in the past five years
- •History of significant heart disease within the previous 6 months
- •Cerebral vascular accident (CVA) or stroke within the previous 6 months.
- •Moderate or severe peripheral neuropathy
- •Previous therapy with other injectable radioisotopes.
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Response Rate
次要结局
- Rate of recurrence
- Toxicity
研究者
研究点 (2)
Loading locations...
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