Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-02 @ 8:32 AM
Study NCT ID:
NCT06246461
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Therapeutic Effect of Different Doses of Capecitabine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficacy:Overall response rate(RR%)', 'timeFrame': 'After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)', 'description': 'Overall response rate (RR%): complete response (CR) + partial response (PR)/total number of cases×100%.'}, {'measure': 'Clinical efficacy:Disease control rate(DR)%', 'timeFrame': 'After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)', 'description': 'Disease control rate (DR)% = (CR+PR+SD)/total number of cases×100%.'}, {'measure': 'Quality of life：QLQ-C30(Quality of Life Questionnaire-core30) Score', 'timeFrame': 'After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)', 'description': '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.'}, {'measure': 'Incidence of adverse reactions', 'timeFrame': 'After the end of all treatment cycles (3 weeks per cycle, a total of four cycles, totaling 84 days)', 'description': '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%'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Capecitabine', 'Advanced colon cancer', 'Clinical efficacy', 'Adverse reactions'], 'conditions': ['Capecitabine']}, 'referencesModule': {'references': [{'pmid': '39132982', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* TNM(tumor node metastasis) clinical stage was III or IV\n* Predicted survival period \\> 3 months\n\nExclusion Criteria:\n\n* Patients with heart, liver, kidney and other important organ failure and contraindications to chemotherapy\n* Patients who received other anti-tumor therapy before admission\n* The disease progressed rapidly and could not be successfully completed by this researcher\n* Allergic to related drugs'}, 'identificationModule': {'nctId': 'NCT06246461', 'briefTitle': 'The Therapeutic Effect of Different Doses of Capecitabine', 'organization': {'class': 'OTHER', 'fullName': "Jingjiang People's Hospital"}, 'officialTitle': 'Clinical Effect Analysis of Different Regimens of Capecitabine in the Treatment of Patients With Advanced Colon Cancer', 'orgStudyIdInfo': {'id': 'JJPH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the control group: a total daily dose of 2,500 mg/m2', 'description': '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.', 'interventionNames': ['Drug: capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the medium-dose group: a total daily dose of 2,000 mg/m2', 'description': '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.', 'interventionNames': ['Drug: capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the low-dose group: a total daily dose of 1,500 mg/m2', 'description': '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.', 'interventionNames': ['Drug: capecitabine']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214500', 'city': 'Jingjiang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Clinical effect analysis of different regimens of capecitabine in the treatment of patients with advanced colon cancer', 'geoPoint': {'lat': 32.01417, 'lon': 120.2625}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Jingjiang People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}