Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00296335
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2006-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Adjuvant Chemotherapy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'C025034', 'term': 'doxifluridine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ykkang@amc.seoul.kr', 'phone': '+82-2-3010-3210', 'title': 'Dr. Yoon-Koo Kang', 'organization': 'Asan Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mitomycin Plus Short-term Fluoropyrimidine', 'description': 'Control arm', 'otherNumAtRisk': 422, 'otherNumAffected': 393, 'seriousNumAtRisk': 422, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati', 'description': 'Experimental arm', 'otherNumAtRisk': 425, 'otherNumAffected': 413, 'seriousNumAtRisk': 425, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 262}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 387}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 393}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 413}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 156}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 162}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 343}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 391}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 326}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 389}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 293}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 371}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 160}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 151}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 219}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 288}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 261}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 334}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 301}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Hand-foot syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 73}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 167}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 108}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI_CTC version 2.0'}], 'seriousEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'NCI_CTC version 2.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'NCI_CTC version 2.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse-free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin Plus Short-term Fluoropyrimidine', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)'}, {'id': 'OG001', 'title': 'Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)'}], 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000', 'lowerLimit': '62.5', 'upperLimit': '71.5'}, {'value': '64.9', 'groupId': 'OG001', 'lowerLimit': '60.4', 'upperLimit': '69.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.\n\nRelapse was defined as any new tumor lesion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to treat population'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin Plus Short-term Fluoropyrimidine', 'description': 'Control arm'}, {'id': 'OG001', 'title': 'Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati', 'description': 'Experimental arm'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '80.9'}, {'value': '73.1', 'groupId': 'OG001', 'lowerLimit': '68.9', 'upperLimit': '77.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin Plus Short-term Fluoropyrimidine', 'description': 'Control arm'}, {'id': 'OG001', 'title': 'Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati', 'description': 'Experimental arm'}], 'classes': [{'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '393', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mitomycin and Doxifluridine', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)'}, {'id': 'FG001', 'title': 'Mitomycin, Doxifluridine and Cisplatin', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '424'}, {'groupId': 'FG001', 'numSubjects': '431'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '309'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '122'}]}], 'dropWithdraws': [{'type': 'Recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}], 'recruitmentDetails': 'AMC0201 was an open-label, prospective randomised phase 3 clinical trial conducted at three centres (Asan medical center, Hallym University medical center, and Ulsan university hospital) in Korea. Patients were enrolled between February 2002 and August 2006', 'preAssignmentDetails': 'All enrolled patients received study treatments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '855', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mitomycin and Doxifluridine', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)'}, {'id': 'BG001', 'title': 'Mitomycin, Doxifluridine and Cisplatin', 'description': 'Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '741', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '53.3', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '855', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled patients were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 855}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2006-02-24', 'resultsFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2006-02-24', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-13', 'studyFirstPostDateStruct': {'date': '2006-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free Survival Rate', 'timeFrame': '3 years', 'description': 'Relapse-free survival at 3 years was defined as the proportion of patients who did not show an evidence of disease recurrence after 3 years of surgery.\n\nRelapse was defined as any new tumor lesion.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival Rate', 'timeFrame': '3 years', 'description': 'Overall survival rate at 3 years was defined as the proportion of patients who were alive at 3 years after surgery.'}, {'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Up to 3 years', 'description': 'Per National Cancer Institute Common Toxicity Criteria version 2.0, up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stomach cancer', 'Adjuvant chemotherapy', 'Mitomycin', 'Cisplatin', 'Doxifluridine'], 'conditions': ['Stomach Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.', 'detailedDescription': "Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.\n\nThis study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven gastric adenocarcinoma\n* Curative resection was done\n* stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)\n* age: 18-69 years old\n* Performance status: ECOG 0-2\n* Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)\n* Adequate renal function (serum creatinine≤ 1.5)\n* Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)\n* Written informed consent was signed by the patient\n\nExclusion Criteria:\n\n* Previous chemotherapy or radiotherapy\n* Active ongoing infection which antibiotic treatment is needed\n* Pregnant or lactating women\n* Psychosis or convulsion disorder\n* Ascites in preoperative abdomen CT\n* Systemic disease which interfere the administration of chemotherapy\n* Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ'}, 'identificationModule': {'nctId': 'NCT00296335', 'briefTitle': 'Trial of Adjuvant Chemotherapy for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AMC-ONCGI-0204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mitomycin and doxifluridine', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)', 'interventionNames': ['Drug: Mitomycin and doxifluridine']}, {'type': 'EXPERIMENTAL', 'label': 'Mitomycin, doxifluridine and cisplatin', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)', 'interventionNames': ['Drug: Mitomycin, doxifluridine and cisplatin']}], 'interventions': [{'name': 'Mitomycin, doxifluridine and cisplatin', 'type': 'DRUG', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)', 'armGroupLabels': ['Mitomycin, doxifluridine and cisplatin']}, {'name': 'Mitomycin and doxifluridine', 'type': 'DRUG', 'description': 'Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)', 'armGroupLabels': ['Mitomycin and doxifluridine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yoon-Koo Kang, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yoon-Koo Kang', 'investigatorAffiliation': 'Asan Medical Center'}}}}