NCT02934685Unknown3 期
A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
Beijing Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemical progression free survival
研究概览
简要总结
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 50-79
- •Histologically confirmed prostate adenocarcinoma
- •Clinical stage T1-3N0M0 according to the AJCC 6th edition
- •Gleason score must be >5
- •No radical surgery or cryosurgery for prostate cancer
排除标准
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
- •Evidence of distant metastases
- •Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer
结局指标
主要结局
Biochemical progression free survival
时间窗: up to 18 months
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
次要结局
- Overall Survival(up to 5 years)
- Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0(From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT)
- Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0(From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT)
研究者
Gaofing Li
director of radiotherapy department
Beijing Hospital
研究点 (1)
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