Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 2:16 PM
Study NCT ID:
NCT00033657
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2002-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], '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'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '617-632-3012', 'title': 'Study Statistician', 'organization': 'Eastern Cooperative Oncology Group (ECOG) Statistical Office'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy', 'eventGroups': [{'id': 'EG000', 'title': 'Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles', 'otherNumAtRisk': 47, 'otherNumAffected': 47, 'seriousNumAtRisk': 47, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.', 'otherNumAtRisk': 46, 'otherNumAffected': 46, 'seriousNumAtRisk': 46, 'seriousNumAffected': 30}, {'id': 'EG002', 'title': 'Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)', 'description': 'Adjuvant chemotherapy toxicities in treated patients', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)', 'otherNumAtRisk': 27, 'otherNumAffected': 25, 'seriousNumAtRisk': 27, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Radiation dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dysphagia-esophageal radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dysphagia-pharyngeal radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Mouth dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Taste disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dizziness/lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anxiety/agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Abonominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Inner ear/hearing imparied', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Arthralgia', 'stats': 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'EG001', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles'}, {'id': 'OG001', 'title': 'Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '28.1'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '29.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible, treated patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles'}, {'id': 'OG001', 'title': 'Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '67.7'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '49.3'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible, treated patients'}, {'type': 'SECONDARY', 'title': 'Recurrence-free Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles'}, {'id': 'OG001', 'title': 'Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'comment': 'The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': 'NA'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '31.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles'}, {'id': 'FG001', 'title': 'Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.'}], 'periods': [{'title': 'Neoadjuvant Chemotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Eligible and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'other complicating disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Not started protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Surgical Resection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'not complete resection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Adjuvant Chemotherapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'E1201 opened to accrual on May 21, 2002 and accrued its first patient on August 15, 2002. A total of 97 patients were accrued from 19 different participating sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cisplatin / Irinotecan / RT (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles'}, {'id': 'BG001', 'title': 'Paclitaxel / Cisplatin / RT (Arm B)', 'description': 'Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '58.1', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2002-04-09', 'resultsFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-21', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response Rate', 'timeFrame': 'approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival Time', 'timeFrame': 'Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.'}, {'measure': 'Recurrence-free Survival Time', 'timeFrame': 'Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry', 'description': 'Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I gastric cancer', 'stage II gastric cancer', 'stage III gastric cancer', 'stage IV gastric cancer', 'stage I esophageal cancer', 'stage II esophageal cancer', 'stage III esophageal cancer', 'stage IV esophageal cancer', 'adenocarcinoma of the stomach', 'adenocarcinoma of the esophagus'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kleinberg L, Powell ME, Forastiere AA, et al.: Survival outcome of E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/radiotherapy (RT) or irinotecan/cisplatin/RT in endoscopy with ultrasound (EUS) staged esophageal adenocarcinoma. [Abstract] J Clin Oncol 26 (Suppl15): A-4532, 2008.'}, {'type': 'RESULT', 'citation': 'Kleinberg LR, Eapen S, Hamilton S, et al.: E1201: an Eastern Cooperative Oncology Group (ECOG) randomized phase II trial to measure response rate and toxicity of preoperative combined modality paclitaxel/cisplatin/RT or irinotecan/cisplatin/RT in adenocarcinoma of the esophagus. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-143, S80, 2006.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.\n* Compare the survival outcome in patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n* Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients.\n* Compare time to progression or recurrence in patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs. 1) and stage of disease (T2-3, N0, M0 vs. T1-3, N0-1, M0 or M1A). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm A: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV (Intravenous) over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.\n* Arm B: Patients receive neoadjuvant radiotherapy as in arm A concurrently with neoadjuvant chemotherapy comprising paclitaxel IV (Intravenous) over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then undergo surgical resection as in arm A. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses.\n\nIn both arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.\n\nACCRUAL: A total of 97 patients (50 on Arm A and 47 on Arm B) were accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction\n\n * Stage T2-3, N0, M0 OR\n * Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)\n* Tumor must be considered surgically resectable (T1-3, but not T4)\n* Age\\>=18 years\n* ECOG Performance status 0-1\n* Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:\n* Granulocyte count at least 1,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Bilirubin no greater than 1.5 mg/dL\n* Creatinine clearance at least 60 mL/min\n* Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years\n* Fertile patients must use effective contraception\n* Endoscopy with biopsy and dilation allowed\n\nExclusion Criteria:\n\n* Tumor extends more than 2 cm into the cardia\n* Pregnant or nursing\n* Other concurrent illness that would preclude study therapy or surgical resection\n* Concurrent filgrastim (G-CSF) during study radiotherapy\n* Prior chemotherapy\n* Prior radiotherapy\n* Prior surgery'}, 'identificationModule': {'nctId': 'NCT00033657', 'briefTitle': 'Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus', 'orgStudyIdInfo': {'id': 'CDR0000069309'}, 'secondaryIdInfos': [{'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}, {'id': 'E1201', 'type': 'OTHER', 'domain': 'Eastern Cooperative Oncology Group (ECOG)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cisplatin / Irinotecan / Radiation therapy (Arm A)', 'description': 'Days 1 - 35 : Concurrent radiation therapy (RT) and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles', 'interventionNames': ['Drug: cisplatin', 'Drug: irinotecan hydrochloride', 'Procedure: conventional surgery', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Paclitaxel / Cisplatin / Radiation therapy (Arm B)', 'description': 'Days 1 - 35 : Concurrent radiation therapy (RT) and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.\n\nDays 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.', 'interventionNames': ['Drug: cisplatin', 'Drug: paclitaxel', 'Procedure: conventional surgery', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['cis-platinum', 'platinum', 'Platinol', 'Platinol-AQ', 'DDP', 'CDDP', 'DACP', 'NSC 119875'], 'description': 'Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29\n\nDays 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles', 'armGroupLabels': ['Cisplatin / Irinotecan / Radiation therapy (Arm A)', 'Paclitaxel / Cisplatin / Radiation therapy (Arm B)']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'otherNames': ['Camptothecin-11', 'CPT-11', 'Camptosar'], 'description': 'Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29\n\nDays 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles', 'armGroupLabels': ['Cisplatin / Irinotecan / Radiation therapy (Arm A)']}, {'name': 'paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol', 'NSC 125973'], 'description': 'Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29\n\nDays 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles', 'armGroupLabels': ['Paclitaxel / Cisplatin / Radiation therapy (Arm B)']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': 'The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.', 'armGroupLabels': ['Cisplatin / Irinotecan / Radiation therapy (Arm A)', 'Paclitaxel / Cisplatin / Radiation therapy (Arm B)']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': 'The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.', 'armGroupLabels': ['Cisplatin / Irinotecan / Radiation therapy (Arm A)', 'Paclitaxel / Cisplatin / Radiation therapy (Arm B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80224', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'CCOP - Colorado Cancer Research Program, Incorporated', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32610-100277', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Cancer Center at the University of Florida Health Science Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611-4494', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Lakeside Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. 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