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Completed

NCT Number: NCT06246461

The Therapeutic Effect of Different Doses of Capecitabine

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.

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Key information

Conditions

Capecitabine

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer

Jingjiang, Jiangsu, 214500, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

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.

Primary outcomes

  1. Clinical efficacy:Overall response rate(RR%)

    Time frame: 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%.

  2. Clinical efficacy:Disease control rate(DR)%

    Time frame: 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%.

  3. Quality of life：QLQ-C30(Quality of Life Questionnaire-core30) Score

    Time frame: 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.

  4. Incidence of adverse reactions

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Jingjiang People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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