Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 4:09 PM
Study NCT ID:
NCT00942357
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2009-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D013812', 'term': 'Therapeutics'}, {'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': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lgedeon@gogstats.org', 'phone': '716-845-1169', 'title': 'Linda Gedeon on behalf of Virginia Filiaci, PhD. and Helen Huang, MS.', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.', 'description': 'All-Cause Mortality will be reported at the end of the study after final data collection is complete. The number currently listed (0) is indicating the data collection is incomplete. The number reported differs from the participant flow because some of the participants were not treated. The number reported are eligible and treated.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy', 'otherNumAtRisk': 346, 'deathsNumAtRisk': 0, 'otherNumAffected': 346, 'seriousNumAtRisk': 346, 'deathsNumAffected': 0, 'seriousNumAffected': 78}, {'id': 'EG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 0, 'otherNumAffected': 360, 'seriousNumAtRisk': 361, 'deathsNumAffected': 0, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Allergy/Immunology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Allergic Reaction/Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 28}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 15}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Autoimmune Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Auditory/Ear - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hearing (Without Monitoring Program)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 13}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 176}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 246}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 217}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 195}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood/Bone Marrow - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bone Marrow Cellularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 287}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 262}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 309}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 292}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac Arrhythmia - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ventricular Arrhythmia - Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac Ischemia/Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 46}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Valvular Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac General - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inr', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Coagulopathy - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ptt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constitutional Symptoms - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 294}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 271}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Photosensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair Loss/Alopecia (Scalp Or Body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 258}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis - Chemoradiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Wound Complication, Non-Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis - Radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hand-Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatology/Skin - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 361, 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis (Functional/Sympt) - Oral Cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis (Clinical Exam) - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 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Disease Progression Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death No Ctcae Term - Death Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, Gi - Ileum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, Gi - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, Gi - Small Bowel Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, Gi - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Gr 3 Or 4 Anc: Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Pelvis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Lymphatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Gr 3 Or 4 Anc: Pelvis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle Weakness - Extremity-Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Head/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Abdominal Pain Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Cardiac/ Heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, Gu - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/Thrombus/Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 346, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Recurrence, Progression or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.', 'description': 'Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of recurrence, progression or death events in eligible and enrolled patients'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment', 'description': 'The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed every 6 months for 3 years', 'description': 'The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible and treated patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'timeFrame': 'From entry into the study to death or the date of last contact, assessed up to 8 years', 'description': 'Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient-reported Peripheral Neuropathy Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.9', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '14.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': '18 weeks', 'categories': [{'measurements': [{'value': '10.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': '70 weeks', 'categories': [{'measurements': [{'value': '11.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment', 'description': 'Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who provided baseline and \\>= 1 follow-up assessment(s)'}, {'type': 'SECONDARY', 'title': 'Patient-reported Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '89.5', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '90.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '18 weeks', 'categories': [{'measurements': [{'value': '87.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '70 weeks', 'categories': [{'measurements': [{'value': '96.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '99.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment', 'description': 'Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who provided baseline and \\>= 1 follow-up assessments'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'FG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '407'}, {'groupId': 'FG001', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}], 'recruitmentDetails': 'GOG 0258 accrued 813 patients between June 29, 2009 and July 28, 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Cisplatin, Radiation Therapy, Paclitaxel, Carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV\n\nInternal Radiation Therapy: Undergo brachytherapy\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nRadiation Therapy: Undergo radiation therapy'}, {'id': 'BG001', 'title': 'Arm II (Paclitaxel and Carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': '80-89 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Endometrial Cancer Grades', 'classes': [{'title': 'Endometrioid Grade 1', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'Endometrioid Grade 2', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}, {'title': 'Endometrioid Grade 3', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Serous', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Clear Cell', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grade 1 is 5% or less of a non-squamous or non-morular solid growth pattern. Grade 2 is 6 through 50% of a non squamous or non-morular solid growth pattern. Grade 3 is more than 50% of a non-squamous or non-morular solid growth pattern. Generally the higher the stage the worse the outcome.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All eligible and treated patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-28', 'size': 598336, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-28T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 813}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-07-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2009-07-17', 'resultsFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2009-07-17', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-17', 'studyFirstPostDateStruct': {'date': '2009-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Recurrence, Progression or Death', 'timeFrame': 'Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years.', 'description': 'Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0', 'timeFrame': 'Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment', 'description': 'The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.'}, {'measure': 'Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0', 'timeFrame': 'Assessed every 6 months for 3 years', 'description': 'The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.'}, {'measure': 'Overall Survival', 'timeFrame': 'From entry into the study to death or the date of last contact, assessed up to 8 years', 'description': 'Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.'}, {'measure': 'Patient-reported Peripheral Neuropathy Symptoms', 'timeFrame': 'Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment', 'description': 'Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.'}, {'measure': 'Patient-reported Quality of Life (QOL)', 'timeFrame': 'Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment', 'description': 'Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometrial Clear Cell Adenocarcinoma', 'Endometrial Serous Adenocarcinoma', 'Stage IA Uterine Corpus Cancer AJCC v7', 'Stage IB Uterine Corpus Cancer AJCC v7', 'Stage II Uterine Corpus Cancer AJCC v7', 'Stage IIIA Uterine Corpus Cancer AJCC v7', 'Stage IIIB Uterine Corpus Cancer AJCC v7', 'Stage IIIC Uterine Corpus Cancer AJCC v7', 'Stage IVA Uterine Corpus Cancer AJCC v7']}, 'referencesModule': {'references': [{'pmid': '39700442', 'type': 'DERIVED', 'citation': "Matei DE, Enserro DM, Randall ME, Mutch D, Small W, DiSilvestro PA, Spirtos NM, O'Malley DM, Cantuaria GH, Michelin D, Waggoner S, Shahin M, Guntupalli S, Lara O, Ueland FR, Warshal D, Bonebrake A, Tewari KS, Tan A, Powell MA, Walker JL, Santin AD, Kim JH, Miller DS. Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma. J Clin Oncol. 2025 Mar 20;43(9):1055-1060. doi: 10.1200/JCO.24.01121. Epub 2024 Dec 19."}, {'pmid': '34903380', 'type': 'DERIVED', 'citation': 'Matulonis UA, Huang HQ, Filiaci VL, Randall M, DiSilvestro PA, Moxley KM, Fowler JM, Powell MA, Spirtos NM, Tewari KS, Richards WE, Nakayama JM, Mutch DG, Miller DS, Matei D, Wenzel LB. Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study. Gynecol Oncol. 2022 Feb;164(2):428-436. doi: 10.1016/j.ygyno.2021.11.021. Epub 2021 Dec 11.'}, {'pmid': '31189035', 'type': 'DERIVED', 'citation': "Matei D, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA, Moxley KM, Kim YM, Powell MA, O'Malley DM, Spirtos NM, Small W Jr, Tewari KS, Richards WE, Nakayama J, Matulonis UA, Huang HQ, Miller DS. Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer. N Engl J Med. 2019 Jun 13;380(24):2317-2326. doi: 10.1056/NEJMoa1813181."}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (\\< 2 cm residual disease) or patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I or II serous (uterine papillary serous carcinoma \\[UPSC\\]) or clear cell endometrial carcinoma and positive cytology.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (i.e., increases survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (\\< 2 cm residual disease) or patients with FIGO 2009 stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.\n\nII. To compare the regimens with respect to acute and late adverse effects of therapy.\n\nIII. To determine the impact of patient-reported quality of life during and following treatment for up to 1 year with the two treatment regimens.\n\nTERTIARY OBJECTIVES:\n\nI. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and whole blood specimens for future research.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo radiation therapy once daily (QD), 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma\n\n * Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement\n * Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis\n* Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology\n* Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional\n* Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2\n* White blood cell (WBC) \\>= 3,000/mcl\n* Absolute neutrophil count (ANC) \\>= 1,500/mcl\n* Platelet count \\>= 100,000/mcl\n* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\\< 2.5 x upper limit of normal (ULN)\n* Alkaline phosphatase =\\< 2.5 times ULN\n* Bilirubin =\\< 1.5 times ULN\n* Creatinine =\\< institutional ULN\n* Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria\n* Patients who have signed an approved informed consent and authorization permitting release of personal health information\n* Entry into the study is limited to no more than 8 weeks from the date of surgery\n\nExclusion Criteria:\n\n* Patients with carcinosarcoma\n* Patients with recurrent endometrial cancer\n* Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension\n* Patients who have had pelvic or abdominal radiation therapy\n* Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma\n* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy\n* Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy\n* Patients with an estimated survival of less than three months\n* Patients with FIGO 2009 stage IVB endometrial cancer\n* Patients with parenchymal liver metastases\n* Patients who have received prior chemotherapy for endometrial cancer\n* Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment'}, 'identificationModule': {'nctId': 'NCT00942357', 'briefTitle': 'Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'GOG-0258'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01951', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10-00685'}, {'id': 'CDR0000649079'}, {'id': 'GOG-0258', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0258', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)', 'description': 'Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cisplatin', 'Radiation: Internal Radiation Therapy', 'Drug: Paclitaxel', 'Other: Quality-of-Life Assessment', 'Radiation: Radiation Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (paclitaxel and carboplatin)', 'description': 'Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)', 'Arm II (paclitaxel and carboplatin)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)']}, {'name': 'Internal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['BRACHYTHERAPY', 'internal radiation', 'Internal Radiation Brachytherapy', 'Radiation Brachytherapy'], 'description': 'Undergo brachytherapy', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax', 'Asotax', 'Bristaxol', 'Praxel', 'Taxol', 'Taxol Konzentrat'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)', 'Arm II (paclitaxel and carboplatin)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)', 'Arm II (paclitaxel and carboplatin)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Irradiate', 'Irradiated', 'irradiation', 'Radiation', 'Radiotherapeutics', 'RADIOTHERAPY', 'RT', 'Therapy, Radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer 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'99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Saint Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Deer Valley Medical Center', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United 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