Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical efficacy:Disease control rate(DR)%
研究概览
简要总结
To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.Different administration regimens of capecitabine were given, and the treatment course was appropriately extended. The therapeutic effect and incidence of adverse reactions were observed.
详细描述
To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.The control group was treated with 2,500 mg/m2 capecitabine, with 2,000 mg/m2 capecitabine for the medium-dose group and 1,500 mg/m2 capecitabine for the low-dose group. Afterward, the response rate, quality of life, and adverse reactions of the three groups were collected for comparison.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the diagnostic criteria for colon cancer in the Consensus on Screening, Diagnosis and Treatment of Early Colorectal Cancer and Precancerous Lesions in China , colon cancer was confirmed by pathology
- •TNM(tumor node metastasis) clinical stage was III or IV
- •Predicted survival period > 3 months
排除标准
- •Patients with heart, liver, kidney and other important organ failure and contraindications to chemotherapy
- •Patients who received other anti-tumor therapy before admission
- •The disease progressed rapidly and could not be successfully completed by this researcher
- •Allergic to related drugs
研究组 & 干预措施
the control group: a total daily dose of 2,500 mg/m2
The control group was treated with capecitabine at a conventional dose: 1,250 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 2,500 mg/m2). Treatment was given for 2 weeks, followed by a 1 week of discontinuation, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.
干预措施: capecitabine (Drug)
the medium-dose group: a total daily dose of 2,000 mg/m2
The medium-dose group was treated with medium-dose capecitabine: 1,000 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 2,000 mg/m2). Treatment was given for 2 weeks, followed by a 1 week of discontinuation, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.
干预措施: capecitabine (Drug)
the low-dose group: a total daily dose of 1,500 mg/m2
The low-dose group was treated with low-dose capecitabine: 750 mg/m2 orally twice daily (once in the morning and once in the evening; equivalent to a total daily dose of 1,500 mg/m2). Treatment was given for 3 weeks per cycle, with each cycle lasting 3 weeks, and there were a total of 4 cycles. Administration: Swallow the tablet whole with water 30 min after breakfast and dinner every day.
干预措施: capecitabine (Drug)
结局指标
主要结局
Clinical efficacy:Disease control rate(DR)%
时间窗: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Disease control rate (DR)% = (CR+PR+SD)/total number of cases×100%.
Clinical efficacy:Overall response rate(RR%)
时间窗: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Overall response rate (RR%): complete response (CR) + partial response (PR)/total number of cases×100%.
Incidence of adverse reactions
时间窗: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Adverse reactions include hand-foot syndrome, stomatitis, leukopenia, nausea and vomiting, bone marrow suppression, and pigmentation. Incidence of adverse reactions%=number of adverse reaction cases/total number of cases × 100%
Quality of life：QLQ-C30(Quality of Life Questionnaire-core30) Score
时间窗: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Quality of life was scored using the QLQ-C30 (Quality of Life Questionnaire-core30).QLQ-C30 is composed of one global quality of life scale and five functional scales, which include physical function, role function, emotional function, cognitive function, and social function. Scoring criteria: After the scores of each part of the scale were converted to standardized scores, the scores ranged from 0 to 100, and the higher the score of the scale, the better the overall quality of life and functional status.
次要结局
未报告次要终点