Capecitabine Metronomic Chemotherapy Versus Conventional Chemotherapy as Maintenance Treatment in Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- PFS1
研究概览
简要总结
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus conventional chemotherapy.
详细描述
In this Prospective, open-label, randomised controlled trial, the investigators will recruit 250 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Then, the patients will be randomised into two group. The experimental group, capecitabine metronomic chemotherapy versus capecitabine conventional chemotherapy as control group. These treatment regimens will be continued until progression, death, or an unacceptable adverse event.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained);
- •Distant metastases (patients with only local recurrence are not eligible);
- •Unidimensionally measurable disease (> 1 cm on spiral CT scan or > 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation;
- •In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.
排除标准
- •Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment;
- •Any prior adjuvant treatment after resection of distant metastases;
- •Previous systemic treatment for advanced disease.
研究组 & 干预措施
Metronomic
accept capecitabine metronomic chemotherapy (500mg, twice per day, everyday)
干预措施: Capecitabine (Drug)
Conventional
accept capecitabine conventional chemotherapy (1000mg/m2, twice per day for 14 days, every 21 days)
干预措施: Capecitabine (Drug)
结局指标
主要结局
PFS1
时间窗: 4 months
from randomizing to progression
次要结局
- QOL(20 months)
- OS(20 months)