An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Percentage of Participants With Pathological Complete Response
研究概览
简要总结
This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is < 100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •adult patients, 18-80 years of age;
- •rectal cancer;
- •planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •previous radiotherapy or chemotherapy for colorectal cancer;
- •clinically significant cardiovascular disease;
- •significant gastric or small intestine disease;
- •serious uncontrolled active infection
研究组 & 干预措施
Capecitabine
Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
干预措施: Standard radiotherapy (Radiation)
Capecitabine
Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.
干预措施: Capecitabine [Xeloda] (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response
时间窗: Up to 11 weeks (assessed at the time of post-treatment surgery)
Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.
次要结局
- Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)(Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy))
- Percentage of Participants With Adverse Events(Up to 15 weeks)
- Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)(Up to 15 weeks (assessed 1 month after surgery))