The Therapeutic Effect of Different Doses of Capecitabine

Jingjiang People's Hospital

Status: Completed

Conditions: Capecitabine

Treatments: Drug: capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06246461

JJPH-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

the control group: a total daily dose of 2,500 mg/m2

Experimental group

Description:

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.

Treatment:

Drug: capecitabine

the medium-dose group: a total daily dose of 2,000 mg/m2

Active Comparator group

Description:

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.

Treatment:

Drug: capecitabine

the low-dose group: a total daily dose of 1,500 mg/m2

Active Comparator group

Description:

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.

Treatment:

Drug: capecitabine