The Therapeutic Effect of Different Doses of Capecitabine

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

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.

Study Overview

• Status: Completed
• Conditions: Capecitabine
• Intervention / Treatment: Drug: capecitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Jingjiang, Jiangsu, China, 214500
      • Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the control group: a total daily dose of 2,500 mg/m2; 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.	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.
Active Comparator: the medium-dose group: a total daily dose of 2,000 mg/m2; 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.	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.
Active Comparator: the low-dose group: a total daily dose of 1,500 mg/m2; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Jingjiang People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Capecitabine; Adverse reactions; Clinical efficacy; Advanced colon cancer
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: JJPH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No