Short-course Preoperative Radiotherapy With Consolidating Chemotherapy vs. Preoperative Chemoradiation in Patients With Unresectable Rectal Cancer: Phase III Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- The rate of patients with R0 resection
研究概览
简要总结
The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addressed the question whether short-course preoperative radiotherapy with consolidating chemotherapy of FOLFOX4 may increase the rate of R0 resection in patients with unresectable rectal cancer.
详细描述
Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in the control arm is conventionally fractionated chemoradiation with 50.4 Gy total dose in 28 fractions of 1.8 Gy over 5.5 weeks simultaneously with 5-Fu, leucovorin and oxaliplatin. Experimental group receive 25 Gy in 5 fractions of 5 Gy over 5 days and after one week interval - consolidating chemotherapy of 3 courses of FOLFOX4. Surgery should be curried out 10-11 weeks from beginning of radiation and at least 4 weeks from the last dose of fluorouracil or radiation. The study hypothesis is that the short-course preoperative radiotherapy with consolidating chemotherapy produce at least 10% increase of the rate of R0 resection compared to preoperative chemoradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
- •WHO performance status ≤
- •Lower border of tumour ≤ 15 cm from anal verge.
排除标准
- •cardiac coronary arterial disease,
- •arrhythmias,
- •stroke even if they have occurred in the past and are controlled with medication
结局指标
主要结局
The rate of patients with R0 resection
时间窗: Surrogate endpoint available immediatly after surgery
次要结局
- The rate of local failures(5 years)
- The rate of distant metastases(5 years)
- The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 3.0)(3 months)
- The rate of postoperative complications(30 days)
- The rate of late toxicity according to the RTOG/EORTC scale(5 years)
- The rate of complete pathological response(Surrogate endpoint available immediatly after surgery)
- Overall long-term survival(5 years)
- Progression-free long-term survival(5 years)