Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 598
- 试验地点
- 68
- 主要终点
- Rate of complete surgical resection
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms of the rate of complete surgical resection, in patients with resectable stage II or III rectal cancer.
Secondary
- Compare overall and disease-free survival of patients treated with these regimens.
- Compare clinical tumor response in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Determine biological parameters that predict tumor response and treatment-related toxicity in patients treated with these regimens.
- Compare sphincter preservation and function in patients treated with these regimens.
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
Radiothérapie + Xelox
干预措施: capecitabine (Drug)
Radiothérapie + Xelox
干预措施: oxaliplatin (Drug)
Radiothérapie + Xelox
干预措施: conventional surgery (Procedure)
Radiothérapie + Xelox
干预措施: neoadjuvant therapy (Procedure)
Radiothérapie + Xelox
干预措施: radiation therapy (Radiation)
Radiothérapie + Capécitabine
干预措施: capecitabine (Drug)
Radiothérapie + Capécitabine
干预措施: conventional surgery (Procedure)
Radiothérapie + Capécitabine
干预措施: neoadjuvant therapy (Procedure)
Radiothérapie + Capécitabine
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Rate of complete surgical resection
次要结局
- Overall survival
- Disease-free survival
- Sphincter preservation
- Sphincter function
- Biological parameters that predict tumor response and treatment-related toxicity
- Acute and late toxicity
