Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-01-20 @ 2:40 PM
Study NCT ID:
NCT00492206
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2007-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tarhiniaa@upmc.edu', 'phone': '412-648-6507', 'title': 'Ahmad Tarhini, MD', 'organization': 'University of Pittsburgh Cancer Institute'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events (AEs) include all AEs (those considered related or unrelated to study treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.', 'otherNumAtRisk': 40, 'otherNumAffected': 38, 'seriousNumAtRisk': 40, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular and nodal arrhythmia, Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular and nodal arrhythmia, Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional Symptoms - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sweating (diaphoresis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatology/Skin - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash: dermatitis associated with radiation, Chemoradiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus/itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash: hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair loss/alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash: dermatitis associated with radiation, Radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash: acne/acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis/stomatitis (clinical exam), Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia (difficulty swallowing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage/Bleeding - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AST, SGOT(serum glutamic oxaloacetic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Magnesium, serum-low (hypomagnesemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal/Soft Tissue - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood alteration, Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurology - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy: motor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood alteration, Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Watery eye (epiphora, tearing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Throat/pharynx/larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Chest/thorax NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary/Upper Respiratory - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional Symptoms - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy), Extraocular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular and nodal arrhythmia, Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Received ≥1 Dose of Cetuximab', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 36 months', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC (N = 38).'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Received ≥1 Dose of Cetuximab', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '17.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 36 months', 'description': 'Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \\[JNCI 92(3):205-216, 2000\\]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with surgically unresectable stage IIIA or IIIB NSCLC. Survival analysis excluded the two ineligible patients with advanced NSCLC.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (ORR) (Number of Participants)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Received Concurrent Radiotherapy + Cetuximab', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'classes': [{'title': 'Complete Response (CR) Rate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response (PR) Rate', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after treatment initiation', 'description': 'The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \\[JNCI 92(3):205-216, 2000\\]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received concurrent radiotherapy + cetuximab + consolidation therapy, and patients who did not receive cetuximab'}, {'type': 'SECONDARY', 'title': 'EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}, {'units': 'baseline tumor tissue', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approx. 5 years', 'description': 'EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.', 'unitOfMeasure': 'percentage of tumors', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'baseline tumor tissue', 'denomUnitsSelected': 'baseline tumor tissue', 'populationDescription': 'Participants with baseline tumor tissue available for EGFR status analysis by fluorescence in situ hybridization (FISH). Akt, pAkt, and MAPKinase analyses were not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects recruited from the surgically unresectable stage IIIA or IIIB NSCLC patient populations', 'preAssignmentDetails': 'Non-Small Cell Lung Cancer, unresectable limited to Stage IIIA/B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca', 'description': 'Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m\\^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'description': 'Age greater than or equal to 18 years of age', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Number of patients with surgically unresectable stage IIIA or IIIB NSCLC accrued'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2007-06-26', 'resultsFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-07', 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to 36 months', 'description': 'Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \\[JNCI 92(3):205-216, 2000\\]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}, {'measure': 'Best Overall Response Rate (ORR) (Number of Participants)', 'timeFrame': 'Up to 12 weeks after treatment initiation', 'description': 'The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \\[JNCI 92(3):205-216, 2000\\]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase', 'timeFrame': 'approx. 5 years', 'description': 'EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non Small Cell Lung Cancer', 'NSCLC', 'EGFR Inhibitor', 'Radiation Therapy'], 'conditions': ['Non Small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.', 'detailedDescription': 'This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer\n* Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion\n* Patients must have measurable disease as per the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\>20 mm with conventional techniques or as \\>10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.\n* Age \\>18 years. Lung cancer is extremely rare in children.\n* ECOG performance status 0-1 (Karnofsky \\>70%; see Appendix A).\n* If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies.\n* Patients must have normal organ and marrow function as defined below:\n* leukocytes \\>3,000/μL\n* absolute neutrophil count \\>1,500/μL\n* platelets \\>100,000/μL\n* total bilirubin within normal institutional limits\n* AST(SGOT)/ALT(SGPT) \\<2.5 X institutional upper limit of normal\n* creatinine within normal institutional limits OR\n* creatinine clearance \\>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal\n* The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.\n* Willingness to sign an approved informed consent.\n\nExclusion Criteria:\n\n* Patients should not have received prior chest radiation therapy.\n* Patients with a history of pulmonary fibrosis are excluded from study.\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study.\n* History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.\n* Prior therapy with known specific inhibitors of the EGFR.\n* History of severe allergic reaction to prior therapy with monoclonal antibodies\n* Peripheral neuropathy of more than grade 1 in severity\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study.\n* Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.\n* Active hepatitis.\n* History of pulmonary fibrosis.'}, 'identificationModule': {'nctId': 'NCT00492206', 'briefTitle': 'Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '05-106'}, 'secondaryIdInfos': [{'id': 'NCT00492206', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuximab', 'description': 'Cetuximab 400 mg/m2 IV week 0 only\n\nExternal beam radiation weeks 1 - 7\n\nCetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7\n\nCetuximab 250 mg/m2 IV weekly weeks 8 - 26\n\nCarboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles', 'interventionNames': ['Drug: Cetuximab']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux, C225'], 'description': 'The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.', 'armGroupLabels': ['Cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Comprehensive Cancer Center, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at John Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '43952', 'city': 'Steubenville', 'state': 'Ohio', 'country': 'United States', 'facility': 'UPMC Cancer Center -Teramana Cancer Center', 'geoPoint': {'lat': 40.36979, 'lon': -80.63396}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Beaver', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '15025', 'city': 'Clairton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center - Clairton', 'geoPoint': {'lat': 40.29229, 'lon': -79.88171}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center - Oakbrook Commons', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Arnold Palmer Pavilion', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15701', 'city': 'Indiana', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Indiana', 'geoPoint': {'lat': 40.62146, 'lon': -79.15253}}, {'zip': '15901', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -John P. Murtha Pavilion', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}, {'zip': '15132', 'city': 'McKeesport', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -McKeesport', 'geoPoint': {'lat': 40.34785, 'lon': -79.86422}}, {'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Haymaker Rd.', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}, {'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Mosside Blvd.', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}, {'zip': '15108', 'city': 'Moon Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Sewickley Medical Center', 'geoPoint': {'lat': 40.50896, 'lon': -80.23923}}, {'zip': '15666', 'city': 'Mount Pleasant', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Mt. Pleasant', 'geoPoint': {'lat': 40.06011, 'lon': -75.18295}}, {'zip': '16105', 'city': 'New Castle', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Jameson', 'geoPoint': {'lat': 41.00367, 'lon': -80.34701}}, {'zip': '16105', 'city': 'New Castle', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -New Castle', 'geoPoint': {'lat': 41.00367, 'lon': -80.34701}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian -Radiation Oncology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15215', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Delafield Rd.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15215', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -St. Margaret', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Universtity of Pittsburgh Cancer Institute -Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -UPMC Shadyside', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Passavant', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Drake', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -St. Clair', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '16346', 'city': 'Seneca', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -UPMC Northwest', 'geoPoint': {'lat': 41.37867, 'lon': -79.70394}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Robert Eberly Pavilion', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Uniontown', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '15301', 'city': 'Washington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Washington', 'geoPoint': {'lat': 40.17396, 'lon': -80.24617}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center -Wexford', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}], 'overallOfficials': [{'name': 'Athanassios Argiris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Translational Science', 'investigatorFullName': 'Ahmad Tarhini', 'investigatorAffiliation': 'University of Pittsburgh'}}}}