The Therapeutic Effect of Different Doses of Capecitabine
- Registration Number
- NCT06246461
- Lead Sponsor
- Jingjiang People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the low-dose group: a total daily dose of 1,500 mg/m2 capecitabine 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. the control group: a total daily dose of 2,500 mg/m2 capecitabine 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. the medium-dose group: a total daily dose of 2,000 mg/m2 capecitabine 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.
- Primary Outcome Measures
Name Time Method Clinical efficacy:Disease control rate(DR)% 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%) 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer
🇨🇳Jingjiang, Jiangsu, China