Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 219
- 试验地点
- 24
- 主要终点
- Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.
详细描述
Adenocarcinoma of the rectum
Stage II/stage III rectal cancer (if T4 only anal extension eligible)
Drug: UFT
Procedure: chemotherapy
Procedure: conventional surgery
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 80 Years（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
研究组 & 干预措施
Tegafur uracile + radiotherapy
干预措施: Tegafur and Uracil (Drug)
radiotherapy
干预措施: Tegafur and Uracil (Drug)
结局指标
主要结局
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone
次要结局
- Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
- Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
- Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
- Compare overall survival
- Compare the rate of sphincter conservation alone.
- Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
- Compare recurrence free survival and disease free survival