Clinical trial NCT06246461: The Therapeutic Effect of Different Doses of Capecitabine
Official title: Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capecitabine
Keywords: Capecitabine
Advanced colon cancer
Clinical efficacy
Adverse reactions
Lead sponsor: Jingjiang People's Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical efficacy:Overall response rate(RR%)
timeFrame: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
measure: Clinical efficacy:Disease control rate(DR)%
timeFrame: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
measure: Quality of life：QLQ-C30(Quality of Life Questionnaire-core30) Score
timeFrame: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
measure: Incidence of adverse reactions
timeFrame: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Jingjiang
country: China
facility: Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer
state: Jiangsu
Study officials:
References: