The Therapeutic Effect of Different Doses of Capecitabine

NCT06246461 | Completed

• 1 other identifier: JJPH-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Capecitabine

Keywords

Capecitabine; Advanced colon cancer; Clinical efficacy; Adverse reactions

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (3)

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

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

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.

the control group: a total daily dose of 2,500 mg/m2; the low-dose group: a total daily dose of 1,500 mg/m2; the medium-dose group: a total daily dose of 2,000 mg/m2

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jingjiang People's Hospital: lead

Study Sites (1)

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

Jingjiang, Jiangsu, 214500, China

Location

Related Publications (1)

• Ju F, Chen K, Yin D. Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer. J Chemother. 2025 Sep;37(5):426-435. doi: 10.1080/1120009X.2024.2385254. Epub 2024 Aug 12.

  PMID: 39132982 DERIVED

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 7, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 22, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

CN (1)