The Therapeutic Effect of Different Doses of Capecitabine

Capecitabine Clinical Trial

Official title:

Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246461
• Other study ID #: JJPH-001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 22, 2024

Study information

• Verified date: January 2024
• Source: Jingjiang People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 22, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Capecitabine

Intervention

Drug:
• capecitabine
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.

Locations

Country	Name	City	State
China	Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer	Jingjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jingjiang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy:Overall response rate(RR%)	Overall response rate (RR%): complete response (CR) + partial response (PR)/total number of cases×100%.	After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Primary	Clinical efficacy:Disease control rate(DR)%	Disease control rate (DR)% = (CR+PR+SD)/total number of cases×100%.	After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Primary	Quality of life:QLQ-C30(Quality of Life Questionnaire-core30) Score	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.	After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Primary	Incidence of adverse reactions	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%	After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)