Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT02583659
Status:
UNKNOWN
Last Update Posted:
2015-11-11
First Post:
2015-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA extracted from peripheral blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival(OS) . overall survival Overall survival(OS)', 'timeFrame': 'From date of enrollment until the date of death from any cause, assessed up to 60 months'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival(PFS)', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months'}, {'measure': 'Objective response rate(ORR)', 'timeFrame': 'The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year'}, {'measure': 'Disease control rate(DCR)', 'timeFrame': 'The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'Through first-line treatment completion,up to 24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric cancer', 'First-line chemotherapy', 'Biomarker'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This prospective cohort study aims to observe the efficacy and safety of the first-line combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.', 'detailedDescription': '1. Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital.\n\n 1.1.Data including age, gender, smoking state, karnofsky performance score（KPS）, disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected.\n\n 1.2.The peripheral blood samples were collected for further biomarker reserch.\n2. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer.\n3. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Histopathology or cytopathology confirmed unresectable locally advanced, or recurrent, or metastatic chemotheapy-naive gastric cancer and gastroesophageal adenocarcinoma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;\n2. Unresectable locally advanced, or recurrent, or metastasis disease；\n3. Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.\n4. Life expectancy of at least 3 months;\n5. ECOG score 0-2;\n6. Voluntarily signed the informed consent.\n\nExclusion criteria:\n\n1. Previously treated with first-line chemotherapy;\n2. First-line chemotherapy with single drug.'}, 'identificationModule': {'nctId': 'NCT02583659', 'briefTitle': 'The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study', 'orgStudyIdInfo': {'id': 'TJCC004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined chemotherapy', 'description': 'AGC patients treated with first-line combined chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianglin Yuan, MD,PHD', 'role': 'CONTACT', 'email': 'yxl@medmail.com.cn', 'phone': '13667241722', 'phoneExt': '1'}, {'name': 'Suxian Wei, Master', 'role': 'CONTACT', 'email': 'wsxattj@126.com', 'phone': '15927421058', 'phoneExt': '1'}, {'name': 'Xianglin Yuan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Suxian Wei, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xianglin Yuan, MD,PHD', 'role': 'CONTACT', 'email': 'yxl@medmail.com.cn', 'phone': '13667241722'}, {'name': 'Suxian Wei, MD', 'role': 'CONTACT', 'email': 'wsxattj@126.com', 'phone': '15927421058'}], 'overallOfficials': [{'name': 'Xianglin Yuan, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief Physician', 'investigatorFullName': 'Xianglin Yuan', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}