Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT00515216
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2007-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alockhar@dom.wustl.edu', 'phone': '314-362-5740', 'title': 'A. Craig Lockhart, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.', 'otherNumAtRisk': 25, 'otherNumAffected': 20, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukopenia (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic reaction/hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '59.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': '* ORR = complete response + partial response\n* Complete response - disappearance of all target and non-target lesions\n* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '16.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 years', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 years', 'description': 'Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '99.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'DCR - complete response, partial response, and stable disease\n\n* Complete response - disappearance of all target and non-target lesions\n* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter\n* Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Specific Changes That May Alter Treatment Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype\n\nChemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)'}], 'timeFrame': '4 years', 'reportingStatus': 'POSTED', 'populationDescription': 'This was not completed as the archived tumor samples were not of sufficient quality for DNA extraction or analysis.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'TYMS, TSER*2/*2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'TYMS, TSER*2/*3 (G)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'TYMS, TSER*2/*3 (C)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G\\>C (rs34743033) gene had a partial tumor response.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': '+6 bp/+6 bp', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '+6 bp/-6 bp', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'C/C', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'C/T', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'T/T', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC1 c.354C\\>T (rs11615) gene had a partial tumor response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'A/C', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'C/C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC2 c.2251A\\>C (rs13181) gene had a partial response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'A/G', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'G/G', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the GSTP1 c.313A\\>G (rs1695) gene had a partial response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'G/A', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'G/G', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the XRCC1 c.1196G\\>A (rs25487) gene had a partial response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'C/C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'C/T', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'T/T', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the MDR1 c.3435C\\>T (rs1045642) gene had a partial response.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '9 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'TYMS, TSER*2/*2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TYMS, TSER*2/*3 (G)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'TYMS, TSER*2/*3 (C)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G\\>C (rs34743033) gene had stable disease.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': '+6 bp/+6 bp', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '+6 bp/-6 bp', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'C/C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'C/T', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'T/T', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC1 c.354C\\>T (rs11615) gene had stable disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'A/C', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'C/C', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC2 c.2251A\\>C (rs13181) gene had stable disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'A/G', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'G/G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the GSTP1 c.313A\\>G (rs1695) gene had stable disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'A/A', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'G/A', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'G/G', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the XRCC1 c.1196G\\>A (rs25487) gene had stable disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}, {'type': 'SECONDARY', 'title': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'classes': [{'title': 'C/C', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'C/T', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'T/T', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the MDR1 c.3435C\\>T (rs1045642) gene had stable disease.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '11 out of 25 participants had a partial response.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype\n\nChemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study opened to participant enrollment in June 2008 and closed to participant enrollment in October 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'TSER genotypes', 'classes': [{'title': 'TSER*2/*2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'TSER*2/*3', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '0 Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours\n4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair\n5. Dead', 'unitOfMeasure': 'participants'}, {'title': 'Primary tumor type', 'classes': [{'title': 'Gastric', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Gastroesophageal junction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Incidence of prior neoadjuvant or adjuvant therapy (>6 months)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2007-08-09', 'resultsFirstSubmitDate': '2015-02-11', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-11', 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '2 years', 'description': '* ORR = complete response + partial response\n* Complete response - disappearance of all target and non-target lesions\n* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '4 years'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '4 years', 'description': 'Progressive disease - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '2 years', 'description': 'DCR - complete response, partial response, and stable disease\n\n* Complete response - disappearance of all target and non-target lesions\n* Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter\n* Stable disease - neither sufficient shrinkage to qualify for partial response not sufficient increase to qualify for progressive disease'}, {'measure': 'Tumor Specific Changes That May Alter Treatment Outcomes', 'timeFrame': '4 years'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G\\>C (rs34743033) gene had a partial tumor response."}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had a partial tumor response."}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC1 c.354C\\>T (rs11615) gene had a partial tumor response.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC2 c.2251A\\>C (rs13181) gene had a partial response.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the GSTP1 c.313A\\>G (rs1695) gene had a partial response.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the XRCC1 c.1196G\\>A (rs25487) gene had a partial response.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Partial Response)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the MDR1 c.3435C\\>T (rs1045642) gene had a partial response.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 5'-UTR TSER + G\\>C (rs34743033) gene had stable disease."}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': "This outcome looks at what genotypes of the TYMS 3'-UTR 1494delTTAAAG(6 bp) (rs34489327) gene had stable disease."}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC1 c.354C\\>T (rs11615) gene had stable disease.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the ERCC2 c.2251A\\>C (rs13181) gene had stable disease.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the GSTP1 c.313A\\>G (rs1695) gene had stable disease.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the XRCC1 c.1196G\\>A (rs25487) gene had stable disease.'}, {'measure': 'Genetic Polymorphisms That May Alter Treatment Outcomes (Stable Disease)', 'timeFrame': '4 years', 'description': 'This outcome looks at what genotypes of the MDR1 c.3435C\\>T (rs1045642) gene had stable disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase II', 'Gastric cancer', 'Gastroesophageal cancer', 'Metastatic', 'FOLFOX', 'Thymidylate synthase', 'Pharmacogenomic'], 'conditions': ['Stomach Neoplasms', 'Esophageal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25232828', 'type': 'DERIVED', 'citation': 'Goff LW, Thakkar N, Du L, Chan E, Tan BR, Cardin DB, McLeod HL, Berlin JD, Zehnbauer B, Fournier C, Picus J, Wang-Gillam A, Lee W, Lockhart AC. Thymidylate synthase genotype-directed chemotherapy for patients with gastric and gastroesophageal junction cancers. PLoS One. 2014 Sep 18;9(9):e107424. doi: 10.1371/journal.pone.0107424. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.vicc.org', 'label': 'Vanderbilt-Ingram Cancer Center'}, {'url': 'http://www.siteman.wustl.edu', 'label': 'Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}, {'url': 'http://cancer.med.unc.edu', 'label': 'UNC Lineberger Comprehensive Cancer Center'}, {'url': 'http://www3.ccc.uab.edu', 'label': 'University of Alabama at Birmingham . Comprehensive Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial therapy for an individual patient. Patients with different genetic backgrounds may respond differently to the same chemotherapy treatments. In this study the investigators will use a certain genetic difference in an important gene (thymidylate synthase or TS gene) to see whether treating patients who have a particular type of that gene will respond better to a standard chemotherapy regimen. The investigators are hoping that by treating patients according to their genes, that they may respond to treatment of their cancer better and it will help the investigators choose cancer treatments better in the future.', 'detailedDescription': 'Gastric and gastroesophageal junction (GEJ) cancers are a leading cause of cancer mortality. Despite the development of newer chemotherapies, the response rates and median survival in patients with these tumors has remained essentially stagnant. Defining host and molecular/biologic tumor characteristics to customize treatment may lead to improved survival outcomes. Retrospective studies have identified genetic markers that predict treatment outcome. However, there have been no prospective studies in gastric and GEJ cancer evaluating the clinical utility of these genetic factors. We hypothesize that genomically based treatment will improve the expected response rate in patients with gastric and GEJ cancers. We propose a prospective, multi-institutional Phase II clinical trial testing a germline polymorphism in the thymidylate synthase (TS) gene, the number of tandem repeats in the TS enhancer region (TSER) as a treatment selection marker. The polymorphic variant conferring three tandem repeats (TSER\\*3) has been associated with 5-FU resistance due to high tumor TS expression in comparison to the TSER\\*2 variant (two tandem repeats). The TSER\\*3 polymorphism is common (allelic frequency of 0.5-0.8). In the proposed study, we will prospectively genotype patients with gastric and GEJ cancers. Patients who are expected to be 5-FU sensitive (carrying a TSER\\*2 allele) will receive a 5-FU containing regimen (5-FU, leucovorin, oxaliplatin). Patients who are expected to be 5-FU resistant (homozygous for TSER\\*3) will not be included in the study. In completing this study, we will determine whether treatment selection based on germline TSER polymorphism status improves the response rate in patients with metastatic gastric and GEJ tumors. Additional correlative studies are proposed to identify confounding factors that may alter the expected outcomes of this treatment approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Patients must have measurable disease.\n* No prior therapy for metastatic disease. Prior neo-adjuvant or adjuvant therapy is permitted if the disease free interval has been longer than 6 months.\n* Age ≥18 years.\n* Life expectancy of greater than 3 months.\n* ECOG (Eastern Cooperative Oncology Group) performance status greater than 2 (Karnofsky greater than 60%).\n* Patients must have normal organ and marrow function.\n* Not pregnant. Not breast feeding.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients may not be receiving any other chemotherapy agents.\n* Patients with known active brain metastases. Patients with treated brain metastases are permitted if stable off steroids for at least 30 days.\n* History of allergic reactions to 5-FU or oxaliplatin.\n* Uncontrolled intercurrent illness.\n* Patients with immune deficiency.'}, 'identificationModule': {'nctId': 'NCT00515216', 'briefTitle': 'Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal (GEJ) Tumors: A Phase II Study', 'orgStudyIdInfo': {'id': '070433'}, 'secondaryIdInfos': [{'id': 'R21CA123881', 'link': 'https://reporter.nih.gov/quickSearch/R21CA123881', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxaliplatin/Leucovorin/5-FU', 'description': '"Good risk" patients with the TSER\\*2/\\*2 or \\*2/\\*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.', 'interventionNames': ['Drug: 5-fluorouracil', 'Drug: Oxaliplatin', 'Drug: Leucovorin']}], 'interventions': [{'name': '5-fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU', 'Fluorouracil'], 'armGroupLabels': ['Oxaliplatin/Leucovorin/5-FU']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'armGroupLabels': ['Oxaliplatin/Leucovorin/5-FU']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Wellcovorin', 'citrovorum factor', 'folinic acid', '5-formyl tetrahydrofolate'], 'armGroupLabels': ['Oxaliplatin/Leucovorin/5-FU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Albert C. Lockhart, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}, {'name': 'Laura Goff, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Richard Goldberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'James Posey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Craig Lockhart', 'investigatorAffiliation': 'Vanderbilt University'}}}}