CapecitabineNCT06246461
The Therapeutic Effect of Different Doses of Capecitabine
A study testing capecitabine in people with Capecitabine, run by Jingjiang People's Hospital at 1 site in China.
Trial 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 =… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Capecitabine
- What is being tested?
- capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer
Jingjiang, Jiangsu, 214500
About this study
Official title: 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.
Read the 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.
- Conditions
- Capecitabine
- Being tested
- capecitabine
- Keywords
- Capecitabine, Advanced colon cancer, Clinical efficacy, Adverse reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy:Overall response rate(RR%)
Overall response rate (RR%): complete response (CR) + partial response (PR)/total number of cases×100%.
Measured: 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%.
Measured: 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.
Measured: 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%
Measured: After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CapecitabineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jingjiang People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246461
- Sponsor's protocol ID
- JJPH-001
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39132982
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT06246461
- Acronym / sponsor ID
- JJPH-001
- Conditions
- Capecitabine
- Keywords
- Capecitabine, Advanced colon cancer, Clinical efficacy, Adverse reactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jingjiang People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the control group: a total daily dose of 2,500 mg/m2 | Experimental | Drug: capecitabineThe 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. |
| the medium-dose group: a total daily dose of 2,000 mg/m2 | Active comparator | Drug: capecitabineThe 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. |
| the low-dose group: a total daily dose of 1,500 mg/m2 | Active comparator | Drug: capecitabineThe 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabineThe 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. | Drug | 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 |
Primary outcome
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%.
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%.
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.
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 39132982Ju 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capecitabine in people with Capecitabine, run by Jingjiang People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06246461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.