Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-09 @ 7:17 PM
Study NCT ID:
NCT02555358
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pathological complete response rate', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall survival(OS)', 'timeFrame': '3 years'}, {'measure': 'Progression-free survival(PFS)', 'timeFrame': '3 years'}, {'measure': 'Disease-free survival(DFS)', 'timeFrame': '3 years'}, {'measure': 'Adverse events', 'timeFrame': '3 years', 'description': "Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resectable advanced gastric cancer'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '1. Zhao Q, Li Y, Tan BB, Tian Y, Jiao ZK, Zhao XF, Zhang ZD, Wang D, Yang PG. XELOX neoadjuvant chemotherapy for advanced gastric cancer resection rate and the impact on prognosis. Journal of Cancer 2013,35 (10) : 773-777 2. Zhao Q, Li Y, Wang GY, Jiao ZK, Zhao XF, Zhang ZD, Tan BB, Zhou CX, Sun WL laparoscopic abdominal control study of gastric cancer resection surgery clinical effect. Chinese General Practice, 2013,16 (1B): 210-215. 3.Zhao Q, Li Y, Tian Y, Chen YN, Tan BB, Zhao XF, Jiao ZK, Zhang ZD, Chang SL. Histological Complete Response after Neoadjuvant XELOX in Advanced Gastric Carcinoma. Hepatogastroenterology. 2013 Jan 24;60(126)'}, {'pmid': '37678277', 'type': 'DERIVED', 'citation': 'Tian Y, Yang P, Guo H, Liu Y, Zhang Z, Ding P, Zheng T, Deng H, Ma W, Li Y, Fan L, Zhang Z, Wang D, Zhao X, Tan B, Liu Y, Zhao Q. Neoadjuvant docetaxel, oxaliplatin plus capecitabine versus oxaliplatin plus capecitabine for patients with locally advanced gastric adenocarcinoma: long-term results of a phase III randomized controlled trial. Int J Surg. 2023 Dec 1;109(12):4000-4008. doi: 10.1097/JS9.0000000000000692.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.', 'detailedDescription': 'Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically proven in operable advanced gastric adenocarcinoma;\n2. Subjects who were identified as potentially resectable cases by a multidisciplinary consultation;\n3. KPS\\> 80; ECOG score: 0-1;\n4. Expected survival\\> 6 months;\n5. Age 20 -60;\n6. Major organ function has to meet the following criteria:\n\n Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function \\<1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine \\<1.5 × UNL, PT-INR / PTT \\<1.7 times the upper limit of normal;\n7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;\n\nExclusion Criteria:\n\n1. Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs;\n2. History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product;\n3. Receiving any form of chemotherapy or other study medication;\n4. Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;\n5. Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.'}, 'identificationModule': {'nctId': 'NCT02555358', 'briefTitle': 'Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Multicenter, Open, Randomized, Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'Alien Craft 0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A（DOX）', 'description': 'Interventions：This arm wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy', 'interventionNames': ['Drug: docetaxel,0xaliplatin,capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B（Xelox）', 'description': 'Interventions：This arm wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy', 'interventionNames': ['Drug: oxaliplatin,capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C（Xelox）', 'description': 'Interventions：This arm wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.', 'interventionNames': ['Drug: oxaliplatin,capecitabine']}], 'interventions': [{'name': 'docetaxel,0xaliplatin,capecitabine', 'type': 'DRUG', 'otherNames': ['AISU,AIHENG,AIBIN'], 'description': 'docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d', 'armGroupLabels': ['A（DOX）']}, {'name': 'oxaliplatin,capecitabine', 'type': 'DRUG', 'otherNames': ['AIHENG,AIBIN'], 'description': 'oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d', 'armGroupLabels': ['B（Xelox）', 'C（Xelox）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Fourth Affiliated Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'overallOfficials': [{'name': 'Qun Zhao, director', 'role': 'STUDY_CHAIR', 'affiliation': 'The 4th Hospital of Hebei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qun Zhao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Surgical director', 'investigatorFullName': 'Qun Zhao', 'investigatorAffiliation': 'Hebei Medical University'}}}}