Phase II Study on Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The reduction of gastrointestinal (GI) toxicity
研究概览
简要总结
The study outlines a clinical prospective protocol consisting of preoperative chemoradiation in locally advanced rectal cancer, without elective pelvic nodal irradiation. The proposal to exclude lateral spaces from the target volume is based on the assumption that the radiological evidence of recurrence in the lateral lymph nodes is shown to be below 5%. In the study all patients underwent an accurate pre-treatment work-up including total body CT, pelvic MRI and 18-fluorodeoxyglucose PET/CT, in order to include patients without evidence of disease in lateral lymph nodes. The primary endpoint of the study was the reduction of gastrointestinal toxicity; secondary endpoints were the pathological complete response (pCR), the local control (LC) rate, the overall survival (OS) and the disease-free survival (DFS).
详细描述
Patients affected by histologically proven rectal cancer were considered for enrollment in a prospective protocol that included preoperative CRT and surgical treatment. All patients underwent pre-treatment work-up (clinical examination, pancolonoscopy with biopsy, total body CT scan, pelvic MRI, and whole body 18-fluorodeoxyglucose PET/CT scan). Eligible patients had primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes. Additional eligibility criteria included performance status as well as liver, kidney, and bone marrow function that allowed for long-course CRT, older than 18 years, and no distant metastases.
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
- •Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes
- •No distant metastases
排除标准
- •Evidence of disease in lateral lymph nodes
- •Distant metastases
研究组 & 干预措施
Primary resectable cT2-low lying-T3, N0-N1 rectal tumour
Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes.
干预措施: Reduced radiation volumes (Radiation)
结局指标
主要结局
The reduction of gastrointestinal (GI) toxicity
时间窗: 36 months
The study is planned to obtain a 66% reduction in acute grade 3 or higher GI side-effects
次要结局
- The local control (LC) rate(36 months)
- The overall survival (OS)(36 months)
- Pathological complete response (pCR)(36 months)
- The disease-free survival (DFS)(36 months)
研究者
Michele Fiore
MD, Researcher
Campus Bio-Medico University