jRCT1030220062招募中不适用
Phase I study of stereotactic body radiotherapy as postoperative adjuvant or salvage therapy for prostate cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Elekta
- 入组人数
- 36
- 主要终点
- Incidence rate of Grade 3 or higher adverse events
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •a) Patients who undergo radical prostatectomy at our hospital for prostate cancer and will receive radiation therapy as adjuvant or salvage therapy at our hospital.
- •b) Performance status (PS): 0-
- •c) Over 18 years old.
- •d) Patients whose pre-registration treatment plan meets the dose constraints.
- •e) A blood test within 28 days prior to the start of radiation therapy meets all of the following:
- •WBC > 3,000 /mm3
- •Hb > 10.0 g/dL
- •Plt > 75,000 /mm3
- •eGFR > 60 mL/min/1.73 m2
- •f) Patients who has given written consent to participate in the study.
排除标准
- •a) Patients who did not consent to participate in the study.
- •b) With lymph node metastasis or distant metastasis.
- •c) With a history of radiation therapy to the pelvis.
- •d) With inflammatory bowel disease such as ulcerative colitis and Crohn's disease.
- •e) With a history of rectal surgery.
- •f) Patients participating in other clinical trials that may affect the conduct or outcome of this study.
- •g) Patients who are judged to be inappropriate to participate in this study by the principal investigater or co-investigaters.
结局指标
主要结局
Incidence rate of Grade 3 or higher adverse events
时间窗: within 90 days after the end of radiation therapy
Grade 3 or higher adverse events that occurred within 90 days after the end of radiation therapy (evaluated by Common terminology Criteria for Adverse Events: CTCAE version 5.0)
次要结局
- QOL changes
- Incidence rate of adverse events within 90 days after radiation therapy(90 days after the end of radiation therapy)
- Incidence rate of adverse events after 91 days of radiation therapy(91 days after the end of radiation therapy)
- Incidence rate of patient-reported adverse events
- Prostate symptoms changes
- Overall survival
- Biochemical recurrence-free survival
研究者
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