Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The tumor regression grade of all the patients enrolled
研究概览
简要总结
The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status (ECOG) 0~2
- •Histologically confirmed colon cancer.
- •No prior treatment
- •CT-defined T4 or lymph node-positive colon cancer
- •Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
- •AST and ALT < 1.5 x ULN
- •Serum creatinine ≤ 1.0 x ULN
- •Life expectancy of ≥ 3 months
- •Signed written informed consent
排除标准
- •Final stage with cancer cachexia
- •Allergy for capecitabine or oxaliplatin
- •Any evidence of extrahepatic metastases and/or primary tumor recurrence
- •Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC
研究组 & 干预措施
Neoadjuvant chemotherapy
A total of 55 cases of locally advanced colon cancer will be enrolled in this arm. After radiological staging, patients were treated first with 3 cycles of neoadjuvant chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by tumor resection, and then with another 5 cycles of adjuvant chemotherapy with the XELOX regimen. Radiological response was evaluated after 2 cycles of neoadjuvant chemotherapy . A total of 3 cycles neoadjuvant chemotherapy was completed unless there was unacceptable toxicity, emergency operation condition or tumor progression during the period. Tumor responses, toxicities, and surgical complications were recorded. The pathological tumor response in the primary tumor was evaluated according to tumor regression grade (TRG) score.
干预措施: capecitabine plus oxaliplatin (Drug)
结局指标
主要结局
The tumor regression grade of all the patients enrolled
时间窗: from the first cycle of treatment (day one) to tumor resection
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(from the first cycle of treatment (day one) to six month after the last cycle)
- Number of Participants receiving complete tumor resection(From date of randomization until the date of the last patients receiving the surgery)