Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer
详细描述
The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of the prostate
- •No lymph node and distant metastasis
- •Age ≥ 20 and < 85 years of age
- •Karnofsky Performance Score ≥70
- •No previous pelvic radiation therapy (RT)
- •No previous prostatectomy
- •No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
- •Ability to understand character and individual consequences of the clinical trial
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
排除标准
- •No pathologically confirmed adenocarcinoma of the prostate
- •Pelvic lymph node metastasis (N1)
- •Distant metastasis (M1)
- •Urinary obstructive symptoms (IPSS > 20)
- •Previous pelvic radiotherapy
- •Previous prostatectomy
- •Severe systemic disorders
- •Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
- •Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
- •Non conformity of the radiotherapy dose distribution when compared to the dose constraints
- •Psychiatric disorders or any other condition that can make unreliable the informed consent
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: From the date of CIRT to 6 months after the completion of CIRT, up to 6 months
次要结局
- Progression-free survival of all patients(From the completion of CIRT, a median of 2 years)
- biochemical failure-free survival，bFFS(From the completion of CIRT, a median of 2 years)
- Overall survival of all patients(From the diagnosis of localized prostate, a median of 2 years)
研究者
Qing Zhang,MD
DIRECTOR
Shanghai Proton and Heavy Ion Center