Capecitabine
Conditions
Keywords
Capecitabine, Advanced colon cancer, Clinical efficacy, Adverse reactions
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.
Interventions
DRUGcapecitabine
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.
Sponsors
Jingjiang People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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%. |
| 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%. |
| 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. |
| 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% |
Countries
China
Outcome results
None listed