The Therapeutic Effect of Different Doses of Capecitabine

NCT ID: NCT06246461

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-22

Brief Summary

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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

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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.

Conditions

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Capecitabine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

capecitabine

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

capecitabine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jingjiang People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Jingjiang, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39132982 (View on PubMed)

Other Identifiers

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JJPH-001

Identifier Type: -

Identifier Source: org_study_id

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