A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 18
- 主要终点
- Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed.
详细描述
OBJECTIVES:
- Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy.
- Determine local recurrence free survival, overall survival, time to appearance of distant metastases, disease free survival and morbidity in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by a number of factors including surgeon.
Patients are randomized to receive preoperative radiotherapy (arm I) or postoperative chemoradiotherapy (arm II).
- Arm I: Patients receive radiotherapy in 5 fractions over 1 week prior to surgery. Patients undergo surgery within 7 days of the last fraction of radiotherapy.
- Arm II: Patients receive chemoradiotherapy 4-12 weeks after surgery (if circumferential resection margins are histologically involved by tumor). Radiotherapy is administered in 25 fractions over 5 weeks (5 days per week). During radiotherapy, patients either receive fluorouracil (5-FU) continuous infusion, 5-FU bolus IV and leucovorin calcium IV weekly, or a 5-day bolus schedule of 5-FU and leucovorin calcium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Local recurrence by biopsy, imaging, or imaging and carcinoembryonic antigen result
次要结局
- Economic implications
- Local recurrence-free survival
- Overall survival
- Time to appearance of distant metastases
- Disease-free survival
- Morbidity
- Quality of life