NCT05911789尚未招募1 期
A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Response rate after surgery
研究概览
简要总结
In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old;
- •Diagnose with rectal cancer;
- •T3-T4 or N+, and no distant metastasis
- •Neoadjuvant chemoradiotherapy intended;
- •Surgery is expected after neoadjuvant therapy;
- •ECOG score 0-2, expected to lie in the treatment bed for at least half an hour;
排除标准
- •With contraindications to rectal MRI;
- •Received surgery, radiotherapy or chemotherapy for rectal cancer;
- •History of pelvic radiotherapy.
结局指标
主要结局
Response rate after surgery
时间窗: 3 monsh after treatment
Clinical and pathological complete response and partial response rate after chemoradiotherapy
Acute toxicities(CTCA
时间窗: 3 months for the start of treatment
evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
次要结局
- Dose coverage of target volume (assessed by planing target volume V100%)(Through study completion, an average of five month)
- Chronic toxicity(2 years after treatment)
- Margins for clinical target volume(CTV) and gross tumor volume (GTV)(Through study completion, an average of five month)
研究者
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