Viewing Study NCT00807768


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Ignite Modification Date: 2026-01-01 @ 4:23 PM
Study NCT ID: NCT00807768
Status: UNKNOWN
Last Update Posted: 2019-03-20
First Post: 2008-12-11
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lgedeon@gogstats.org', 'phone': '716-845-1169', 'title': 'Linda Gedeon for Virginia Filiaci, PhD', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 283, 'otherNumAffected': 245, 'seriousNumAtRisk': 283, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 290, 'otherNumAffected': 284, 'seriousNumAtRisk': 290, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Allergic Reaction/Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 17}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hearing (Without Monitoring Program)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 227}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 135}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood/Bone Marrow - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 234}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 206}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'S/N Arrhythmia: Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac General - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inr', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Coagulopathy - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ptt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rigors/Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 192}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nail Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, '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': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 188}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis - Chemoradiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, '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': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis - Radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hand-Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatology/Skin - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 17}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis (Functional/Sympt) - Larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Incontinence, Anal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis (Functional/Sympt) - 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'CTCAE (3.0)'}, {'term': 'Pain: Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Pain Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Abdominal Pain Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Scalp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Middle Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Anus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nasal/Paranasal Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Voice Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction, Gu - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Incontinence, Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bladder Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 30}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': '2nd Mal: Poss. Related To Cancer Rx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sexual/Reproductive Function: Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syndromes - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu-Like Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/Thrombus/Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardipulmonary Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death No Ctcae Term - Death Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf Unknown Anc: Lung (Pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood Alteration - Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain: Chest Wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Peripheral Arterial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/Thrombus/Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 290, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Recurrence or Death Events at Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years', 'description': 'Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Death Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Overall survival is measured from study enrollment for up to 10 years.', 'description': 'The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sites of Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Vaginal recurrence', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pelvic or PA node', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Distant recurrence', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years', 'description': 'Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Patient Reported Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '4 Weeks', 'categories': [{'measurements': [{'value': '35.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '10-11 Weeks', 'categories': [{'measurements': [{'value': '40.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '8 Months', 'categories': [{'measurements': [{'value': '42.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '14 Months', 'categories': [{'measurements': [{'value': '40.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment', 'description': 'Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 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 Fatigue 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 FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Provided baseline and \\>= follow-up assessments'}, {'type': 'SECONDARY', 'title': 'Patient-reported Neurotoxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': '4 Weeks', 'categories': [{'measurements': [{'value': '14.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '10-11 Weeks', 'categories': [{'measurements': [{'value': '14.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '8 Months', 'categories': [{'measurements': [{'value': '14.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': '14 Months', 'categories': [{'measurements': [{'value': '13.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.', 'description': 'Patient reported neurotoxicity symptoms as 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 suggesting less neurotoxicity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Provided baseline and ≥ follow-up assessments'}, {'type': 'SECONDARY', 'title': 'Patient-reported Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '98.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '4 Weeks', 'categories': [{'measurements': [{'value': '91.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '92.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '10-11 Weeks', 'categories': [{'measurements': [{'value': '98.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '95.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '8 Months', 'categories': [{'measurements': [{'value': '101.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '99.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': '14 Months', 'categories': [{'measurements': [{'value': '99.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment', 'description': 'Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI 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 in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Provided baseline and \\>= follow-up assessments'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gene Expression Based Risk Score', 'timeFrame': 'Baseline', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'GOG 0249 accrued 601 patients from March 2009 to February 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Pelvic Radiation Therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\n3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy\n\nIntensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG001', 'title': 'Arm II (Brachytherapy, Paclitaxel, Carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nInternal Radiation Therapy: Undergo vaginal cuff brachytherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}, {'title': '>=70 years', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cell Type', 'classes': [{'title': 'Endometrioid, grade 1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Endometrioid, grade 2', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}, {'title': 'Endometrioid, grade 3 or not graded', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Serous', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Clear Cell', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grade 1 endometrioid endometrial cancers are well differentiated. Grade 2 tumors are moderately differentiated. Grade 3 tumors are poorly differentiated. Lower grades have a higher relapse free survival rate..', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Enrolled patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-28', 'size': 542504, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-24T17:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2008-12-11', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2008-12-11', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-27', 'studyFirstPostDateStruct': {'date': '2008-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gene Expression Based Risk Score', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Recurrence or Death Events at Primary Analysis', 'timeFrame': 'Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years', 'description': 'Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Death Events', 'timeFrame': 'Overall survival is measured from study enrollment for up to 10 years.', 'description': 'The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.'}, {'measure': 'Number of Participants With Sites of Recurrence', 'timeFrame': 'Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years', 'description': 'Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event.'}, {'measure': 'Patient Reported Fatigue', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment', 'description': 'Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 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 Fatigue 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 FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.'}, {'measure': 'Patient-reported Neurotoxicity', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.', 'description': 'Patient reported neurotoxicity symptoms as 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 suggesting less neurotoxicity.'}, {'measure': 'Patient-reported Quality of Life', 'timeFrame': 'Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment', 'description': 'Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI 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 in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometrial Clear Cell Adenocarcinoma', 'Endometrial Serous Adenocarcinoma', 'Fatigue', 'Neurotoxicity Syndrome', 'Obesity', 'Stage I Uterine Corpus Cancer AJCC v7', 'Stage II Uterine Corpus Cancer AJCC v7']}, 'referencesModule': {'references': [{'pmid': '30995174', 'type': 'DERIVED', 'citation': 'Randall ME, Filiaci V, McMeekin DS, von Gruenigen V, Huang H, Yashar CM, Mannel RS, Kim JW, Salani R, DiSilvestro PA, Burke JJ, Rutherford T, Spirtos NM, Terada K, Anderson PR, Brewster WR, Small W, Aghajanian CA, Miller DS. Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer. J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. It is not yet known whether pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if treatment with vaginal cuff brachytherapy followed by three cycles of chemotherapy reduces the rate of recurrence or death (i.e. increases recurrence-free survival) when compared to pelvic radiation therapy.\n\nSECONDARY OBJECTIVES:\n\nI. To compare survival between the two treatment groups. II. To compare patterns of failure between the two treatment groups. III. To compare physical functioning, fatigue and neurotoxicity between the two treatment groups.\n\nIV. To examine associations between primary comorbid illnesses and obesity on survival, fatigue and physical functioning.\n\nV. To evaluate the psychometric properties (such as construct validity, reliability, sensitivity to treatment and responsiveness over time) of the Patient-Reported-Outcomes Measurement Information System (PROMIS) Fatigue Short form 1, and to evaluate fatigue measurement equivalence between women with endometrial cancer and age-matched women from the general United States (US) population.\n\nTERTIARY OBJECTIVES:\n\nI. To evaluate the ability of gene expression signatures in early stage endometrial cancer to predict recurrence and to explore the association between gene expression signatures in early stage endometrial cancer and clinical characteristics and outcome.\n\nII. To bank whole blood specimens for future research.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.\n\nARM II: Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter for up to 5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be considered eligible to participate in this trial, all patients must have undergone hysterectomy; bilateral salpingo-oophorectomy (open or laparoscopic approach) is strongly encouraged\n* Peritoneal cytology should be obtained on entering the peritoneal cavity, as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual (https://gogmember.gog.org/manuals/pdf/surgman.pdf); pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged (as staged patients enrolled on GOG-0210-molecular markers in endometrial carcinoma are eligible for this study)\n\n * The procedures may be performed via laparotomy or laparoscopy (including robot-assisted) as per the surgeon?s preference; the surgeon must record in the operative report whether a lymphadenectomy was performed (see link above to Surgical Procedures Manual) or not; a specific number of lymph nodes removed will not be utilized for eligibility, but the operative report should reflect that the procedure performed was consistent with the procedures described in the GOG Surgical Manual\n* If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment computed tomography (CT)/magnetic resonance imaging (MRI) is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease); post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed\n* For the purposes of description, patients will be staged according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 staging system; eligibility is defined based on clinical-pathologic features; patients with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:\n\n * Age \\>= 70 years with one risk factor\n * Age \\>= 50 with 2 risk factors\n * Age \\>= 18 years with 3 risk factors\n * Risk factors: grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ? myometrial invasion; patients with these risk criteria may be enrolled with either positive or negative cytology\n* Patients with stage II endometrial carcinoma (any histology) with cervical stromal invasion (occult or gross involvement), with or without high-intermediate risk factors\n* Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement), and with peritoneal cytology negative for malignancy\n* Patients must have GOG performance status 0, 1, or 2\n* Absolute neutrophil count (ANC) \\>= 1,500/mcl (equivalent to Common Toxicity Criteria \\[CTCAE version \\[v\\] 3.0\\] grade 1)\n* Platelets \\>= 100,000/mcl (CTCAE v3.0 grade 0-1)\n* Serum creatinine =\\< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0\n\n * Note: If serum creatinine \\> ULN, a 24-hour creatinine clearance must be collected and must be \\> 50 mL/min\n* Bilirubin =\\< 1.5 x ULN (CTCAE v3.0 grade 1)\n* Serum glutamic oxaloacetic transaminase (SGOT) =\\< 2.5 x ULN (CTCAE grade 0-1)\n* Alkaline phosphatase =\\< 2.5 x ULN (CTCAE grade 0-1)\n* Neuropathy (sensory and motor) =\\< CTCAE v3.0 grade 1\n* Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria\n* Patients must have signed an approved informed consent and authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients who have already received non-surgical therapy for endometrial cancer including chemotherapy, radiation (example, pre-operative or post-operative brachytherapy), hormonal or biologic therapy\n* Patients identified with pathologically confirmed spread of cancer beyond the uterus and cervix to pelvic or para-aortic lymph nodes, adnexal structures, and/or other anatomic sites, or patients with serous or clear cell histology and with positive cytologic washings\n* Patients with nodal (for patients who did not have nodal dissection performed) or distant disease determined based on imaging studies; patients with suspicious nodes that have been biopsied (re-staging operation, fine needle aspiration \\[FNA\\]) and are pathologically negative will be eligible\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 other malignancy being present within the last 5 years; patients are excluded if their previous cancer treatment contraindicates this protocol therapy; specifically, patients who have received prior radiotherapy directed to treat disease within the abdominal cavity or pelvis are excluded\n* Prior radiation of localized cancer of the breast, head and neck, thyroid, or skin is permitted, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease\n* Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 5 years prior to registration, and the patient remains free of recurrent or metastatic disease\n* Patients who have contraindications to pelvic radiation therapy (RT) (e.g. pelvic kidney, connective tissue disease, inflammatory bowel disease, etc.) should be screened in advance and not be considered eligible for the trial\n* Patients with recurrent endometrial cancer\n* Patients with surgical or clinical, FIGO 2009 stage III or IV endometrial carcinoma\n* Patients with non-epithelial uterine malignancies such as uterine carcinosarcoma or leiomyosarcoma'}, 'identificationModule': {'nctId': 'NCT00807768', 'briefTitle': 'Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'GOG-0249'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00610', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000629591'}, {'id': 'GOG-0249', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'GOG-0249', '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': 'ACTIVE_COMPARATOR', 'label': 'Arm I (pelvic radiation therapy)', 'description': 'Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Radiation: Intensity-Modulated Radiation Therapy', 'Radiation: Internal Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (brachytherapy, paclitaxel, carboplatin)', 'description': 'Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Radiation: Internal Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Drug: Paclitaxel', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': '3-Dimensional Conformal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['3-dimensional radiation therapy', '3D CONFORMAL RADIATION THERAPY', '3D CRT', '3D-CRT', 'Conformal Therapy', 'Radiation Conformal Therapy'], 'description': 'Undergo pelvic radiation therapy', 'armGroupLabels': ['Arm I (pelvic radiation therapy)']}, {'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 II (brachytherapy, paclitaxel, carboplatin)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy'], 'description': 'Undergo pelvic radiation therapy', 'armGroupLabels': ['Arm I (pelvic radiation therapy)']}, {'name': 'Internal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['BRACHYTHERAPY', 'internal radiation', 'Internal Radiation Brachytherapy', 'Radiation Brachytherapy'], 'description': 'Undergo vaginal cuff brachytherapy', 'armGroupLabels': ['Arm I (pelvic radiation therapy)', 'Arm II (brachytherapy, paclitaxel, carboplatin)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (pelvic radiation therapy)', 'Arm II (brachytherapy, paclitaxel, carboplatin)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax', 'Asotax', 'Bristaxol', 'Praxel', 'Taxol', 'Taxol Konzentrat'], 'description': 'Given IV', 'armGroupLabels': ['Arm II (brachytherapy, paclitaxel, carboplatin)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (pelvic radiation therapy)', 'Arm II (brachytherapy, paclitaxel, carboplatin)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (pelvic radiation therapy)', 'Arm II (brachytherapy, paclitaxel, carboplatin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'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': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates-West Orange Grove', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center-North Campus', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Auburn', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center/Disney Family Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '95682', 'city': 'Cameron Park', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Cameron Park', 'geoPoint': {'lat': 38.66879, 'lon': -120.98716}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Medical Center-Concord Campus', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center-Todd Cancer Institute', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Gynecologic Oncology', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Oakland-Broadway', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Saint Joseph Hospital - Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Redwood City', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94801', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Richmond', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '94928', 'city': 'Rohnert Park', 'state': 'California', 'country': 'United States', 'facility': 'Rohnert Park Cancer Center', 'geoPoint': {'lat': 38.33964, 'lon': -122.7011}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Roseville Medical Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Medical Center Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Mercy General Hospital Radiation Oncology Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United 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Teresa-San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94903', 'city': 'San Rafael', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-San Rafael', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-Santa Rosa', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente-South San Francisco', 'geoPoint': 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