AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- complete pathological response (pCR)
研究概览
简要总结
Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy
详细描述
AIDA-RE-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. In neoadjuvant setting, patients are treated with standard chemotherapy plus experimental radiotherapy. The total dose to clinical target volume (CTV, rectum and locoregional lymph nodes) is 45 Gy, with a concomitant boost of 5 Gy to gross tumor volume (GTV), delivered with IMRT-SIB (intensity modulated radiotherapy-simultaneous integrated boost) technique in 25 fractions. After 2 weeks of treatment, patients are evaluated with 18 FDG-PET and sequential boost of 5 Gy (in 2 fractions) is planned.
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
- •histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved
排除标准
- •familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
- •severe cardiopathy
- •previous pelvic RT
结局指标
主要结局
complete pathological response (pCR)
时间窗: 6 weeks
pCR is defined as ypT0N0
次要结局
- Acute toxicity(6 months)
- Late toxicity(1 year)
- Quality of Life (QoL)(1 year)
- Dosimetric advantage of GTV-boost reduction(6 weeks)
- Evaluation of PET-response as predictive factor(1 year)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna