NCT05807984尚未招募2 期
A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer
Xin Cai1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- local control
研究概览
简要总结
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis,
- •received a radical operation for their primary tumor and regional lymph nodes,
- •received chemo-radiation or radiation in pelvic before CIRT,
- •received re-irradiation by CIRT after their pelvic radiotherapy.
排除标准
- •received more than once prior radiotherapy in the same treatment field,
- •time to the last radiotherapy was <1 year,
- •space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).
结局指标
主要结局
local control
时间窗: Local control at 3 years after CIRT
local control rate of the lesion treated by CIRT
次要结局
- progression free survival(3 years after CIRT or patient died, measured erery 3 months after CIRT)
- overall survival(3 years after CIRT or patient died, measured erery 3 months after CIRT)
研究者
Xin Cai
Deputy chief physician
Shanghai Proton and Heavy Ion Center
研究点 (1)
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