Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT01372202
Status:
TERMINATED
Last Update Posted:
2019-01-25
First Post:
2011-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CHFR Methylation Status Esophageal Cancer Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkelly25@jhmi.edu', 'phone': '443-287-0005', 'title': 'Ronan Kelly, MD', 'organization': 'SKCCC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 7, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Arm B', 'description': 'Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fu: Oxaliplatin \\& 5-fu:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \\& completing on the final day of radiation\n\nCisplatin/5-fluorouracil:\n\n* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Arm C', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 3, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-responsive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathological Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fu: Oxaliplatin \\& 5-fu:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \\& completing on the final day of radiation\n\nCisplatin/5-fluorouracil:\n\n* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Cisplatin or Oxaliplatin, 5-Fluorouracil along , Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hs days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fluorouracil: Oxaliplatin and 5-fluorouracil:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'Cisplatin with 5-Fluorouracil with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\n 5-Fluorouracil: Oxaliplatin and 5-fluorouracil:\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks star'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Overall survival with given treatment strategy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Cisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fluorouracil: Oxaliplatin and 5-fluorouracil:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the opera'}, {'id': 'OG002', 'title': 'Arm C', 'description': 'Cisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\n 5-Fluorouracil: Oxaliplatin and 5-fluorouracil:\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks star'}], 'timeFrame': '3 years', 'description': 'To determine time to disease progression with this treatment strategy.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Esophageal Tumor CHFR Methylation and Detection in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fu: Oxaliplatin \\& 5-fu:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \\& completing on the final day of radiation\n\nCisplatin/5-fluorouracil:\n\n* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.'}, {'id': 'OG002', 'title': 'Cisplatin With 5 Fu', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy'}], 'timeFrame': '3 years', 'description': 'To determine the agreement between tumor CHFR methylation and detection in plasma.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'FG001', 'title': 'Arm B', 'description': 'Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fu: Oxaliplatin \\& 5-fu:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \\& completing on the final day of radiation\n\nCisplatin/5-fluorouracil:\n\n* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.'}, {'id': 'FG002', 'title': 'Cisplatin With 5 Fu', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy\n\nPaclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.\n\nEsophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).'}, {'id': 'BG001', 'title': 'Arm B', 'description': 'Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy\n\nCisplatin: Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nOxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29.\n\n5-Fu: Oxaliplatin \\& 5-fu:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \\& completing on the final day of radiation\n\nCisplatin/5-fluorouracil:\n\n* 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.\n\nRadiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.'}, {'id': 'BG002', 'title': 'Arm C', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '72'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '76'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '73'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '47', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Study stopped due to early stopping rule', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-28', 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response', 'timeFrame': '3 years', 'description': 'CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '3 years', 'description': 'Overall survival with given treatment strategy.'}, {'measure': 'Time to Disease Progression', 'timeFrame': '3 years', 'description': 'To determine time to disease progression with this treatment strategy.'}, {'measure': 'Esophageal Tumor CHFR Methylation and Detection in Plasma', 'timeFrame': '3 years', 'description': 'To determine the agreement between tumor CHFR methylation and detection in plasma.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Operable', 'Based on CHFR Methylation Status', 'Diagnostic Biopsies'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.', 'detailedDescription': 'Primary Objectives\n\n• To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.\n\nSecondary Objectives\n\n* To determine the survival outcome with this treatment strategy.\n* To determine time to disease progression with this treatment strategy.\n* To determine the agreement between tumor CHFR methylation and detection in plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the esophagus or GE junction\n2. Patient must be untreated with chemotherapy, radiation therapy, or surgery for this diagnosis of esophageal cancer. (Endoscopy with biopsy and dilation is permitted.)\n3. Tumor must be located between 20 cm from the teeth endoscopically and 2 cm into the gastric cardia. Cervical esophageal cancers and true gastric cancers are excluded.\n4. Stage T2-3/N0-3/M0 as determined by imaging studies and biopsy where appropriate. T4 disease is permitted if defined as resectable by the thoracic surgeon (involvement of the pleura, pericardium or diaphragm).\n5. Patients must have had an endoscopic ultrasound\n6. Patients must have had a staging PET scan\n7. Age ≥ 18 and ≤ 75\n8. ECOG performance status 0-1.\n9. Surgically resectable tumor\n10. Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds three years.\n11. Patients must have adequate organ and marrow function as defined below:\n\n * absolute neutrophil count ≥ 1,000/mcL\n * platelets ≥ 100,000/mcL\n * total bilirubin ≤ 2 mg/dL\n * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN\n * creatinine \\< 1.5 X institutional ULN\n12. Female patients must not be pregnant or breast feeding. Radiotherapy is associated with significant birth defects and/or non-viable fetus. Paclitaxel, cisplatin, oxaliplatin, and 5-fluorouracil have teratogenic potential. A negative pregnancy test is required within 14 days of treatment for all women of childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately.\n13. Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patients may not be receiving any investigational agents.\n2. Incomplete healing from previous major surgery.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents they are assigned to.\n4. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels paclitaxel. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.\n5. Uncontrolled, inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. HIV-positive patients on combination antiretroviral therapy are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n7. Patients from whom biopsy tissue cannot be obtained for correlate study analysis."}, 'identificationModule': {'nctId': 'NCT01372202', 'acronym': 'J10130', 'briefTitle': 'CHFR Methylation Status Esophageal Cancer Study', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies', 'orgStudyIdInfo': {'id': 'J10130'}, 'secondaryIdInfos': [{'id': 'NA_00042668', 'type': 'OTHER', 'domain': 'JHMIRB'}, {'id': 'R33CA127055', 'link': 'https://reporter.nih.gov/quickSearch/R33CA127055', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Cisplatin', 'Radiation: Radiotherapy', 'Procedure: Esophagectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Cisplatin or Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy', 'interventionNames': ['Drug: Cisplatin', 'Drug: Oxaliplatin', 'Drug: 5-Fluorouracil', 'Radiation: Radiotherapy', 'Procedure: Esophagectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm C', 'description': 'Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy', 'interventionNames': ['Drug: Cisplatin', 'Drug: 5-Fluorouracil', 'Radiation: Radiotherapy', 'Procedure: Esophagectomy']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane', 'Taxol'], 'description': 'Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.', 'armGroupLabels': ['Arm A']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Platinol'], 'description': 'Paclitaxel and cisplatin:\n\n* Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.\n* Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.\n* Cisplatin 75 mg/m² days 1, 29.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Oxaliplatin 85 mg/m2 days 1, 15, 29.', 'armGroupLabels': ['Arm B']}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU', 'Adrucil', 'Carac', 'Efudex', 'Fluorouracil'], 'description': 'Oxaliplatin and 5-fluorouracil:\n\n* Oxaliplatin 85 mg/m2 days 1, 15, 29.\n* 5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)\n\nCisplatin and 5-fluorouracil:\n\n* 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.\n* Cisplatin 75 mg/m² days 1, 29.', 'armGroupLabels': ['Arm B', 'Arm C']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['IMRT'], 'description': 'Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}, {'name': 'Esophagectomy', 'type': 'PROCEDURE', 'otherNames': ['Resection'], 'description': 'The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Ronan Kelly, M.D.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ronan Kelly, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}