Viewing Study NCT00438659


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Study NCT ID: NCT00438659
Status: COMPLETED
Last Update Posted: 2016-08-01
First Post: 2007-02-20
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miller.robert@mayo.edu', 'title': 'Robert C. Miller, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.', 'otherNumAtRisk': 84, 'otherNumAffected': 75, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.', 'otherNumAtRisk': 82, 'otherNumAffected': 81, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 235, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 263, 'numAffected': 69}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 83, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 81, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Atrophy skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 137, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 214, 'numAffected': 69}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 42, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 48, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Skin hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 21, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Skin striae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numEvents': 24, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).', 'unitOfMeasure': 'Grade', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe ( Grade >=3) Radiation Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'classes': [{'title': 'Did not experience grade >=3 radiation dermatitis', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Experience grade >=3 radiation dermatitis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.', 'unitOfMeasure': 'Paticipants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Toxicity as Measured by the Skin Toxicity Assessment Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'classes': [{'title': 'STAT: Discomfort/Burning', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'STAT: Itching', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'STAT: Pulling', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'STAT: Discomfort/Tenderness', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.', 'unitOfMeasure': 'Score on a 0 to 5 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).', 'unitOfMeasure': 'score on a 0-6 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not completed due to too little incidence of the dermatitis.'}, {'type': 'SECONDARY', 'title': 'Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '16', 'groupId': 'OG000'}, {'value': '82', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed at least 1 assessment were evaluable for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'QOL Domains as Measured by LASA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.'}], 'classes': [{'title': 'Mental well-being', 'categories': [{'measurements': [{'value': '86', 'spread': '15', 'groupId': 'OG000'}, {'value': '84', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Physical well-being', 'categories': [{'measurements': [{'value': '83', 'spread': '17', 'groupId': 'OG000'}, {'value': '79', 'spread': '19', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being', 'categories': [{'measurements': [{'value': '85', 'spread': '16', 'groupId': 'OG000'}, {'value': '80', 'spread': '19', 'groupId': 'OG001'}]}]}, {'title': 'Social well-being', 'categories': [{'measurements': [{'value': '81', 'spread': '19', 'groupId': 'OG000'}, {'value': '77', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': 'Spiritual well-being', 'categories': [{'measurements': [{'value': '89', 'spread': '14', 'groupId': 'OG000'}, {'value': '84', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed at least 1 assessment were evaluable for this secondary end point.'}, {'type': 'SECONDARY', 'title': 'Adverse Events Assessed Clinically by NCI CTCAE v3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'classes': [{'title': 'ARTHRALGIA: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BURN: Mild', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'BURN: Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'BURN: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'CELLULITES INFECTN: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'COUGH: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DERMATOLOGY: Mild', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'DERMATOLOGY: Moderate', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'DERMATOLOGY: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'FATIGUE: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PAIN: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PAIN-BREAST: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PAIN-CHEST: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PRURITUS: Mild', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'PRURITUS: Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'PRURITUS: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'SKIN ATROPHY: Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'SKIN ATROPHY: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SKIN HYPOPIGMENT: Mild', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'SKIN HYPOPIGMENT: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SKIN IRRITATION: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SKIN STRIAE: Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'SKIN STRIAE: Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.'}], 'classes': [{'title': 'Redness', 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'Dry Peeling', 'categories': [{'measurements': [{'value': '2.7', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'Wet Peeling', 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Weeping', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in color', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Band, Stripes or Lines', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Discontinued Mometasone/Placebo', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Cancel', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Total of 176 patients were enrolled on this trial between 9/21/07 and 12/07/2007. There were 7 cancels (5 in Arm A and 2 in Arm B) and 3 patients discontinued treatment (1 in Arm A and 2 in Arm B). In total 84 in Arm A and 82 in Arm B were evaluable for the primary endpoint.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '14.63', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '89'}, {'value': '57', 'spread': '11.8', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '85'}, {'value': '59', 'spread': '13.29', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All (169) eligible patients are included in the baseline analysis. There were 5 cancels in Arm I and 2 in Arm II.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-01', 'studyFirstSubmitDate': '2007-02-20', 'resultsFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-11', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Severe ( Grade >=3) Radiation Dermatitis', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.'}, {'measure': 'Skin Toxicity as Measured by the Skin Toxicity Assessment Tool', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.'}, {'measure': 'Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).'}, {'measure': 'Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis.', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.', 'description': 'To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.'}, {'measure': 'Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).'}, {'measure': 'QOL Domains as Measured by LASA', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.'}, {'measure': 'Adverse Events Assessed Clinically by NCI CTCAE v3.0', 'timeFrame': 'During Radiation Treatment, up to a maximum of 9 weeks.'}, {'measure': 'Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).', 'timeFrame': 'During Radiation Treatment, up to a maximum of 11 weeks.', 'description': 'Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dermatologic complications', 'skin reactions secondary to radiation therapy', 'radiation toxicity', 'breast cancer in situ', 'recurrent breast cancer', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'male breast cancer', 'ductal breast carcinoma in situ', 'stage IV breast cancer'], 'conditions': ['Breast Cancer', 'Dermatologic Complications', 'Radiation Toxicity', 'Skin Reactions Secondary to Radiation Therapy']}, 'referencesModule': {'references': [{'pmid': '21922203', 'type': 'BACKGROUND', 'citation': 'Atherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16.'}, {'pmid': '20800381', 'type': 'RESULT', 'citation': 'Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA. Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: a phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1460-6. doi: 10.1016/j.ijrobp.2010.01.031. Epub 2010 Aug 26.'}, {'pmid': '20888137', 'type': 'RESULT', 'citation': 'Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC. Comparison of provider-assessed and patient-reported outcome measures of acute skin toxicity during a Phase III trial of mometasone cream versus placebo during breast radiotherapy: the North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):397-402. doi: 10.1016/j.ijrobp.2010.05.065. Epub 2010 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.\n\nPURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.\n\nSecondary\n\n* Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.\n* Compare the time to onset and duration of severe radiation dermatitis in these patients.\n* Assess skin toxicity and quality of life of these patients.\n* Assess the adverse event profile of mometasone furoate in these patients.\n* Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast \\[post-lumpectomy\\] vs chest wall \\[post-mastectomy\\]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs \\> 55 Gy). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.\n* Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.\n\nPatients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.\n\nAfter completion of radiotherapy, patients are followed for 2 weeks.\n\nPROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ\n* Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:\n\n * Whole breast (as part of breast-conservation therapy)\n * Chest wall (as part of post-mastectomy irradiation)\n\n * Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed\n* Must meet the following criteria for planned radiotherapy:\n\n * Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy\n * No planned split-course radiotherapy\n * No partial breast treatment, defined as treatment of \\< 75% of the breast parenchyma\n * Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed\n* Must be entered on study within 7 days prior to beginning radiotherapy\n\n * Must start study drug prior to receiving the third radiotherapy fraction\n* No preexisting skin breakdown within the planned radiotherapy field at the time of study entry\n* No bilateral breast cancer treatment\n* No inflammatory carcinoma of the breast\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Male or female\n* Menopausal status not specified\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to complete questionnaires independently or with assistance\n* No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior radiotherapy to the planned radiotherapy treatment area\n* No concurrent or planned leukotriene inhibitors, including the following:\n\n * Zafirleukast\n * Monteleukast\n * Zileuton\n* No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:\n\n * Cortaid®\n * Cortizone 10®\n * Tucks®\n * Preparation H®\n* No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment'}, 'identificationModule': {'nctId': 'NCT00438659', 'briefTitle': 'Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy', 'orgStudyIdInfo': {'id': 'NCCTG-N06C4'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02708', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000530309', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mometasone', 'description': 'Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.', 'interventionNames': ['Drug: mometasone furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'mometasone furoate', 'type': 'DRUG', 'description': 'Applied to treatment area', 'armGroupLabels': ['Mometasone']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Applied to treatment area', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60507', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush-Copley Cancer Care Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Joseph Medical Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Graham Hospital', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '61530', 'city': 'Eureka', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eureka Community Hospital', 'geoPoint': {'lat': 40.72143, 'lon': -89.27286}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Clinic, PC', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Cottage Hospital', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'InterCommunity Cancer Center of Western Illinois', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '62644', 'city': 'Havana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mason District Hospital', 'geoPoint': {'lat': 40.30004, 'lon': -90.06095}}, {'zip': '61747', 'city': 'Hopedale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hopedale Medical Complex', 'geoPoint': {'lat': 40.42087, 'lon': -89.41454}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associates, Limited - West', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '61443', 'city': 'Kewanee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Kewanee Hospital', 'geoPoint': {'lat': 41.24559, 'lon': -89.92483}}, {'zip': '61455', 'city': 'Macomb', 'state': 'Illinois', 'country': 'United States', 'facility': 'McDonough District Hospital', 'geoPoint': {'lat': 40.45921, 'lon': -90.6718}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'facility': 'Trinity Cancer Center at Trinity Medical Center - 7th Street Campus', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'BroMenn Regional Medical Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Cancer Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Hospital of Ottawa', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61350', 'city': 'Ottawa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Hematology Associates of Central Illinois, PC - Ottawa', 'geoPoint': {'lat': 41.34559, 'lon': -88.84258}}, {'zip': '61554', 'city': 'Pekin', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Treatment Center at Pekin Hospital', 'geoPoint': {'lat': 40.56754, 'lon': -89.64066}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Proctor Hospital', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61615-7827', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Illinois Oncology Research Association', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Hematology Associates of Central Illinois, PC - Peoria', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61636', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center of Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61354', 'city': 'Peru', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Valley Community Hospital', 'geoPoint': {'lat': 41.32753, 'lon': -89.12897}}, {'zip': '61356', 'city': 'Princeton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Perry Memorial Hospital', 'geoPoint': {'lat': 41.36809, 'lon': -89.46481}}, {'zip': '61362', 'city': 'Spring Valley', 'state': 'Illinois', 'country': 'United States', 'facility': "St. Margaret's Hospital", 'geoPoint': {'lat': 41.32754, 'lon': -89.19981}}, {'zip': '61362', 'city': 'Spring Valley', 'state': 'Illinois', 'country': 'United States', 'facility': 'Valley Cancer Center', 'geoPoint': {'lat': 41.32754, 'lon': -89.19981}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center at Carle Foundation Hospital', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '46515', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'Elkhart General Hospital', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '46904', 'city': 'Kokomo', 'state': 'Indiana', 'country': 'United States', 'facility': 'Howard Community Hospital', 'geoPoint': {'lat': 40.48643, 'lon': -86.1336}}, {'zip': '46350', 'city': 'La Porte', 'state': 'Indiana', 'country': 'United States', 'facility': 'Center for Cancer Therapy at LaPorte Hospital and Health Services', 'geoPoint': {'lat': 41.60774, 'lon': 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'United States', 'geoPoint': {'lat': 41.52448, 'lon': -90.51569}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cedar Rapids Oncology Associates', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '50307', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Capitol Hospital', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Iowa Oncology Research Association', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'John Stoddard Cancer Center at Iowa Methodist Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates at John Stoddard Cancer Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Oncology and Hematology Associates at Mercy Cancer Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy Medical Center - Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50316', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'John Stoddard Cancer Center at Iowa Lutheran Hospital', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '50401', 'city': 'Mason City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy Medical Center - North Iowa', 'geoPoint': {'lat': 43.15357, 'lon': -93.20104}}, {'zip': '52501', 'city': 'Ottumwa', 'state': 'Iowa', 'country': 'United States', 'facility': 'McCreery Cancer Center at 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