NCT01040624已完成不适用
A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Acute Grade 3 or Higher Treatment-related Toxicity Rate.
研究概览
简要总结
The purpose of this study is to see what effects, good and/or bad, proton based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •* Adenocarcinoma of the prostate.
排除标准
- •Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation.
- •Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.)
- •History of hip replacement.
- •Prior intrapelvic surgery. This includes the following:
- •Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding
- •Transabdominal pelvic surgery
- •Bladder surgery
- •Prior myocardial infarction (MI) or congestive heart failure (CHF).
- •Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
结局指标
主要结局
Acute Grade 3 or Higher Treatment-related Toxicity Rate.
时间窗: 6 months after the completion of radiation therapy
Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.
次要结局
- Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.(After radiation: every 6 months for 3 years, then annually for 20 years)
- Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.(After radiation: every 6 months for 3 years, then annually for 20 years)
研究者
研究点 (2)
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