Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- DDC:Duration of Disease Control
研究概览
简要总结
Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
详细描述
Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).
- •Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent
排除标准
- •Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
研究组 & 干预措施
Placebo
Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
干预措施: placebo (Other)
Capecitabine
Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
干预措施: Capecitabine (Drug)
结局指标
主要结局
DDC:Duration of Disease Control
时间窗: 2 years
progression-free survival of first-line chemotherapy with second-line chemotherapy
次要结局
- OS:Overall Survival(2 years)
- DCR:Disease Control Rate(2 years)
研究者
Dong Yan
Beijing Chao Yang Hospital
Beijing Chao Yang Hospital