A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
详细描述
For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal adenocarcinoma confirmed by histopathology
- •MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
- •The age is 18-75 years old, no gender limit
- •The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1
排除标准
- •History of other malignant tumors;
- •They were allergic to 5-FU, platinum, etc;
- •The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
- •After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
- •History of gastrointestinal fistula, perforation or severe ulcer;
- •At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
研究组 & 干预措施
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
干预措施: Concurrent Chemoradiotherapy Radiotherapy (Combination Product)
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
干预措施: Adjuvant chemotherapy (Drug)
Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
干预措施: TME (Procedure)
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: Short-course Radiotherapy (Radiation)
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: Consolidation chemotherapy (Drug)
Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: TME (Procedure)
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: Local dose increase of Short-course Radiotherapy (Radiation)
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: Consolidation chemotherapy (Drug)
Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
干预措施: TME (Procedure)
结局指标
主要结局
R0 resection rate
时间窗: 1 year
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
次要结局
- 3yDMFS(3 years)
- 3yLRRFS(3 years)
- 3y OS(3 years)
研究者
Jing Jin, M.D.
Clinical Professor, Radiotherapy Department
Chinese Academy of Medical Sciences