Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT03636893
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjsurgeon@hotmail.com', 'phone': '0086-64370045', 'title': 'Dr BIRENDRA KUMAR SAH', 'phoneExt': '671302', 'organization': 'RUIJIN HOSPITAL'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a preliminary result of phase II study with inadequate sample numbers. A phase III multi center randomised controlled trial is necessary to justify these results.'}}, 'adverseEventsModule': {'timeFrame': 'From randomization through 5 years follow-up (median follow-up 65.7 months)', 'description': 'All 74 randomized participants were assessed for all-cause mortality per intention-to-treat analysis. According to the study protocol, serious adverse events and other adverse events were systematically collected for all 74 participants during the study period, including events leading to treatment discontinuation. Adverse events leading to dropout were captured as protocol violations or serious adverse events as appropriate.', 'eventGroups': [{'id': 'EG000', 'title': 'FLOT Chemotherpy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nThree drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 9, 'seriousNumAtRisk': 40, 'deathsNumAffected': 21, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nTwo drug Chemotherapy: Oxaliplatin+TGO', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 5, 'seriousNumAtRisk': 34, 'deathsNumAffected': 20, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Grade 3+Grade 4 Decrease in white blood cells', 'notes': 'Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0:\n\nDecrease in white blood cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Grade 3+Grade 4 Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Grade 3+Grade 4 Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute bleeding requiring emergency surgery', 'notes': 'Acute bleeding requiring emergency surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Overall postoperative complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative complications: Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Grade IV hematological toxicity with multiple organ failure', 'notes': 'Grade IV hematological toxicity with multiple organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute cerebral infarction', 'notes': 'Acute cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep venous thrombosis', 'notes': 'Deep venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOT Chemotherpy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nThree drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin'}, {'id': 'OG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nTwo drug Chemotherapy: Oxaliplatin+TGO'}], 'classes': [{'categories': [{'title': 'Grade 1a: Complete tumor regression', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 1b: Subtotal tumor regression', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Grade 2: Partial tumor regression', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Grade 3: Minimal or no tumor regression', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Pathology not available', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Three months', 'description': 'Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: \\<10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: \\>50% residual tumor per tumor bed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOT Chemotherapy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nFLOT Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin'}, {'id': 'OG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nSOX Chemotherapy: Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '38.0'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '38.9'}]}]}], 'analyses': [{'pValue': '0.842', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.060', 'ciLowerLimit': '0.597', 'ciUpperLimit': '1.884', 'pValueComment': 'P-value from two-sided log-rank test. Alpha level set at 0.05.', 'estimateComment': 'Hazard ratio from Cox proportional hazards regression with FLOT as reference group.', 'groupDescription': 'Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.', 'nonInferiorityComment': 'Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \\<0.05.', 'otherAnalysisDescription': 'Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization through 5 years follow-up (median follow-up 65.7 months)', 'description': 'Time from randomization to the first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.\n\nDisease recurrence was assessed using CT imaging with contrast, upper endoscopy for local recurrence, histological confirmation when feasible, and multidisciplinary team review of imaging findings.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population including all 74 randomized patients regardless of treatment completion or protocol adherence. Complete vital status obtained for all patients with median follow-up of 65.7 months.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOT Chemotherapy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nFLOT Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin'}, {'id': 'OG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nSOX Chemotherapy: Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'comment': 'Upper CI limit not estimable - median survival not reached due to \\>50% of FLOT patients remaining alive at data cutoff.', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': 'NA'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '25.7', 'upperLimit': '109.9'}]}]}], 'analyses': [{'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.101', 'ciLowerLimit': '0.595', 'ciUpperLimit': '2.036', 'pValueComment': 'P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.', 'estimateComment': 'Hazard ratio from Cox proportional hazards regression with FLOT as reference group.', 'groupDescription': 'Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.', 'nonInferiorityComment': 'Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \\<0.05.', 'otherAnalysisDescription': 'Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization through 5 years follow-up (median follow-up 65.7 months)', 'description': 'Time from randomization to death from any cause. Patients alive at the time of analysis were censored on the date of the last follow-up visit. Vital status was verified through multiple sources: direct clinical follow-up, telephone contact, cross-referencing with local death registry records, and review of medical records from other healthcare facilities.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population including all 74 randomized patients regardless of treatment completion or protocol adherence. Complete vital status obtained for all patients. At data cut-off, 41 deaths occurred: 21 (52.5%) in FLOT group and 20 (58.8%) in SOX group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLOT Chemotherpy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consists of Day 1 5-fluorouracil (5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter (PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nThree drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin'}, {'id': 'FG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nTwo drug Chemotherapy: Oxaliplatin+TGO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refusal to surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Early surgery (for acute bleeding)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FLOT Chemotherpy Regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consists of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day\n\nThree drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin'}, {'id': 'BG001', 'title': 'SOX Chemotherapy Regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day\n\nTwo drug Chemotherapy: Oxaliplatin+TGO'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=60', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '61-70', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '71-80', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.56', 'groupId': 'BG000', 'lowerLimit': '15.69', 'upperLimit': '29.48'}, {'value': '23.49', 'groupId': 'BG001', 'lowerLimit': '17.31', 'upperLimit': '27.82'}, {'value': '23.56', 'groupId': 'BG002', 'lowerLimit': '15.69', 'upperLimit': '29.48'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Per protocol(PP) population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-10', 'size': 163856, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-14T18:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomly assigned(1:1) either to FLOT or SOX group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2018-08-01', 'resultsFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-03', 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour', 'timeFrame': 'Three months', 'description': 'Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: \\<10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: \\>50% residual tumor per tumor bed'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'From randomization through 5 years follow-up (median follow-up 65.7 months)', 'description': 'Time from randomization to the first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.\n\nDisease recurrence was assessed using CT imaging with contrast, upper endoscopy for local recurrence, histological confirmation when feasible, and multidisciplinary team review of imaging findings.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization through 5 years follow-up (median follow-up 65.7 months)', 'description': 'Time from randomization to death from any cause. Patients alive at the time of analysis were censored on the date of the last follow-up visit. Vital status was verified through multiple sources: direct clinical follow-up, telephone contact, cross-referencing with local death registry records, and review of medical records from other healthcare facilities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant chemotherapy', 'perioperative chemotherapy', 'Systemic chemotherapy', 'FLOT', 'SOX', 'Gastric cancer'], 'conditions': ['Gastric Cancer', 'Chemotherapy Effect']}, 'referencesModule': {'references': [{'pmid': '41181842', 'type': 'DERIVED', 'citation': 'Sah BK, Yu Z, Zhang B, Yuan F, Zhang H, Li J, Ma T, Shi M, Zhu Z, Zheng Y, Liu W, Yan C, Li C, Zhu Z. Neoadjuvant FLOT versus SOX chemotherapy in locally advanced gastric cancer: secondary outcomes of a single-centre, open-label, randomised, exploratory phase 2 trial. EClinicalMedicine. 2025 Oct 5;88:103494. doi: 10.1016/j.eclinm.2025.103494. eCollection 2025 Oct.'}, {'pmid': '33257672', 'type': 'DERIVED', 'citation': 'Sah BK, Zhang B, Zhang H, Li J, Yuan F, Ma T, Shi M, Xu W, Zhu Z, Liu W, Yan C, Li C, Liu B, Yan M, Zhu Z. Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer. Nat Commun. 2020 Nov 30;11(1):6093. doi: 10.1038/s41467-020-19965-6.'}]}, 'descriptionModule': {'briefSummary': 'Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China', 'detailedDescription': 'DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.\n* Clinical stage: cTNM: stage III or above\n* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)\n* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.\n* Written informed consent\n\nExclusion criteria:\n\n* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia\n* Confirmed distant metastases\n* Locally advanced inoperable disease (Clinical assessment)\n* Relapse of gastric cancer\n* Malignant secondary disease\n* Prior chemo or radiotherapy\n* Inclusion in another clinical trial\n* Known contraindications or hypersensitivity for planned chemotherapy'}, 'identificationModule': {'nctId': 'NCT03636893', 'briefTitle': 'Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Dragon III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLOT Chemotherapy regimen', 'description': 'A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered\n\nA cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous\n\nRepeated every 15th day', 'interventionNames': ['Drug: FLOT Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOX Chemotherapy regimen', 'description': 'Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered\n\nA cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)\n\nRepeated every 21st day', 'interventionNames': ['Drug: SOX Chemotherapy']}], 'interventions': [{'name': 'FLOT Chemotherapy', 'type': 'DRUG', 'otherNames': ['FLOT'], 'description': '5-FU+Leucovorin+Docetaxel+Oxaliplatin', 'armGroupLabels': ['FLOT Chemotherapy regimen']}, {'name': 'SOX Chemotherapy', 'type': 'DRUG', 'otherNames': ['SOX'], 'description': 'Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)', 'armGroupLabels': ['SOX Chemotherapy regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Birendra Kumar Sah, PH D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Chen Li, PH D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ruijin Hospital'}, {'name': 'Zhenggang Zhu, PH D', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'BIRENDRA KUMAR SAH', 'investigatorAffiliation': 'Ruijin Hospital'}}}}