Viewing Study NCT00686166

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:43 PM

Ignite Modification Date: 2026-01-05 @ 6:24 PM

Study NCT ID: NCT00686166

Status: COMPLETED

Last Update Posted: 2018-05-18

First Post: 2008-05-28

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '206-667-4408', 'title': 'SWOG Statistician', 'organization': 'SWOG Statistical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 years', 'description': 'Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.', 'eventGroups': [{'id': 'EG000', 'title': 'Chemotherapy', 'description': 'Patients receive oxaliplatin 50 mg/m\\^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m\\^2 IV (Day 1), cetuximab 250 mg/m\\^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m\\^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.', 'otherNumAtRisk': 74, 'otherNumAffected': 73, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Chemotherapy + Radiation', 'description': 'Patients receive oxaliplatin 50 mg/m\\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.', 'otherNumAtRisk': 68, 'otherNumAffected': 66, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tumor Resection', 'description': 'Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.', 'otherNumAtRisk': 63, 'otherNumAffected': 51, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry mouth/salivary gland (xerostomia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhage, GI - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Incontinence, anal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (clinical exam) - Oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symp) - Oral cav', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis/stomatitis (functional/symp) - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Abdomen NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Anus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: dermatitis associated w/Chemoradiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: dermatitis associated w/radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukocytes (total WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic/Laboratory-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Magnesium, serum-low (hypomagnesemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium, serum-low (hypokalemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sodium, serum-low (hyponatremia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle weakness, not d/t neuropathy - body/general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Taste alteration (dysgeusia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary frequency/urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary retention (including neurogenic bladder)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hair loss/Alopecia (scalp or body)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritus/itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: acne/acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash: hand-foot skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death - Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acidosis (metabolic or respiratory)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Adult respiratory distress syndrome (ARDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathologic Complete Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemo + Chemo and Radiation + Surgery', 'description': 'Chemotherapy Cycle 1 (1 cycle is 35 days):\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n* Cetuximab, 400 mg/m\\^2, IV, Day 1\n* Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n* Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2:\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78\n* Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78\n* Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)\n* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.\n\nTherapeutic Surgical procedure: Resection'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '37'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Exact binomal test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '15-20 weeks from registration', 'description': 'Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and analyzable patients with available data. It was assumed that a pathologic complete response was not achieved for patients who do not receive surgery or for whom a surgical specimen is lacking. These patients were included in the denominator.'}, {'type': 'SECONDARY', 'title': '3-year Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemo + Chemo and Radiation + Surgery', 'description': 'Chemotherapy Cycle 1 (1 cycle is 35 days):\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n* Cetuximab, 400 mg/m\\^2, IV, Day 1\n* Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n* Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2:\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78\n* Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78\n* Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)\n* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.\n\nTherapeutic Surgical procedure: Resection'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and analyzable patients'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chemotherapy', 'description': 'Patients receive oxaliplatin 50 mg/m\\^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m\\^2 IV (Day 1), cetuximab 250 mg/m\\^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m\\^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.'}, {'id': 'OG001', 'title': 'Chemotherapy + Radiation', 'description': 'Patients receive oxaliplatin 50 mg/m\\^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m\\^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m\\^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.'}, {'id': 'OG002', 'title': 'Tumor Resection', 'description': 'Surgery must take place between 3 - 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.'}], 'classes': [{'title': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'AST, SGOT', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Acidosis (metabolic or respiratory)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Adult respiratory distress syndrome (ARDS)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, serum-low (hypoalbuminemia)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Allergic reaction/hypersensitivity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Allergic rhinitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Amylase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, serum-low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin (hyperbilirubinemia)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Blood/Bone Marrow-Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bone: spine-scoliosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bruising (in absence of Gr 3-4 thrombocytopenia)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Burn', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Calcium, serum-low (hypocalcemia)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Coagulation-Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Colitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Constitutional Symptoms-Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Cystitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Cytokine release syndrome/acute infusion reaction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dermatology/Skin-Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Distention/bloating, abdominal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Dry mouth/salivary gland (xerostomia)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dry skin', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Dysphagia (difficulty swallowing)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea (shortness of breath)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Edema: limb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Enteritis (inflammation of the small bowel)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Extrapyramidal/involuntary movement/restlessness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (asthenia, lethargy, malaise)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Fever in absence of neutropenia, ANC lt1.0x10e9/L', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Flatulence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Flu-like syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Flushing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastritis (including bile reflux gastritis)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal-Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose, serum-high (hyperglycemia)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hair loss/Alopecia (scalp or body)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Heartburn/dyspepsia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage, GI - Rectum', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage/Bleeding-Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhage/bleeding w/surgery, intra- or post-op', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hemorrhoids', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hepatobiliary/Pancreas-Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hiccoughs (hiccups, singultus)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hot flashes/flushes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperpigmentation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': 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'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Vascular-Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ventricular arrhythmia - Ventricular tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vision-blurred vision', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Weight gain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Wound complication, non-infectious', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 years', 'description': 'Only adverse events that are possibly, probably or definitely related to study regimen are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who received any treatment and were assessed for adverse events are included in this summary.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chemo + Chemo and Radiation + Surgery', 'description': 'Chemotherapy Cycle 1 (1 cycle is 35 days):\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n* Cetuximab, 400 mg/m\\^2, IV, Day 1\n* Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n* Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2:\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78\n* Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78\n* Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)\n* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.\n\nTherapeutic Surgical procedure: Resection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}]}, {'type': 'Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'Eligible and Began Protocol Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Progression/Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not Protocol Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Did not begin protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chemo + Chemo and Radiation + Surgery', 'description': 'Chemotherapy Cycle 1 (1 cycle is 35 days):\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n* Cetuximab, 400 mg/m\\^2, IV, Day 1\n* Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n* Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2:\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78\n* Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78\n* Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)\n* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.\n\nTherapeutic Surgical procedure: Resection'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'groupId': 'BG000', 'lowerLimit': '25.5', 'upperLimit': '77.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', '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': '63', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible patients who began protocol therapy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2008-05-28', 'resultsFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-26', 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic Complete Response Rate', 'timeFrame': '15-20 weeks from registration', 'description': 'Pathologic response is evaluated after the patient has had surgery, and is based on local pathology review of the resected surgical specimen, according to the following: a) Pathologic complete response (pCR): on review of the resected rectal specimen and accompanying lymph nodes, no cancer is recognized by the pathologist; b) Microscopic cancer: gross tumor is not seen by the pathologist but tumor remains in the microscopic analysis of any part of the entire specimen; c) no response: gross cancer is found on pathologic examination of the resected rectal cancer and draining lymph nodes.'}], 'secondaryOutcomes': [{'measure': '3-year Disease-free Survival', 'timeFrame': '3 years', 'description': 'From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.'}, {'measure': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.', 'timeFrame': 'Up to 4 years', 'description': 'Only adverse events that are possibly, probably or definitely related to study regimen are reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the rectum', 'stage IIA rectal cancer', 'stage IIB rectal cancer', 'stage IIC rectal cancer', 'stage IIIA rectal cancer', 'stage IIIB rectal cancer', 'stage IIIC rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase II trial is studying the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III rectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To assess the pathologic complete response rate for the combination of oxaliplatin, capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for patients with adenocarcinoma of the rectum, stages II and III with wild-type K-ras.\n* To estimate the 3-year disease-free survival probability in this patient population when treated with this regimen.\n* To assess the frequency and severity of toxicities associated with this regimen in these patients.\n* To explore, preliminarily, the association between expression levels of genes involved in the DNA repair, EGFR (epidermal growth factor receptor), angiogenesis, and 5-FU pathway (i.e., k-ras, TS \\[Thymidylate Synthase\\], ERCC-1 \\[excision repair cross complementing-1), TP \\[Thymidine phosphorylase\\], DPD \\[Dihydropyrimidine dehydrogenase\\], EGFR, VEGF \\[vascular endothelial growth factor\\], and IL-8 \\[interleukin-8\\]) and pathologic complete response. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)\n* To explore, preliminarily, the intratumoral gene expression levels of these genes after completion of study treatment.(Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)\n* To obtain, preliminarily, data on genomic polymorphisms of these genes for correlation with clinical outcome and toxicity. (Due to advances in methodology, the translational medicine objectives are being reconsidered. Therefore, results for this objective are not reported)\n\nOUTLINE: This is a multicenter study.\n\n* Neoadjuvant therapy (course 1): Patients receive oxaliplatin IV over 2 hours once a week for 5 weeks, oral capecitabine twice daily 5 days a week for 5 weeks, and cetuximab IV over 1-2 hours once a week for 5 weeks.\n* Neoadjuvant therapy with concurrent radiotherapy (course 2): Beginning two weeks later, patients receive oxaliplatin IV over 2 hours once a week in weeks 1, 2, 4, and 5. Patients also receive capecitabine and cetuximab as in course 1. Patients also undergo external beam radiotherapy 5 days a week for 5 weeks beginning in week 1.\n\nTreatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 3-8 weeks after completion of chemoradiotherapy.\n\nBlood samples are collected for germline polymorphism testing and tissue samples are collected and assessed for gene expression analysis.\n\nAfter completion of study treatment, patients are followed every 6 months for 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Biopsy-proven primary adenocarcinoma of the rectum\n\n * Stage II or III disease\n * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination\n * No recurrent disease\n* Must have wild-type k-ras status\n* Measurable and/or nonmeasurable disease\n\nPATIENT CHARACTERISTICS:\n\n* Zubrod performance status 0-2\n* Leukocyte count ≥ 3,000/mcL\n* Granulocyte count ≥ 1,500/mcL\n* Platelet count ≥ 100,000/mcL\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase ≤ 2.5 times ULN\n* SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN\n* Creatinine clearance \\> 50 mL/min\n* No prior severe reaction to a monoclonal antibody\n* Willing to have specimens submitted\n* No peripheral neuropathy ≥ grade 2\n* No known existing uncontrolled coagulopathy\n* No evidence of current high-grade obstruction\n\n * At least 2 weeks since prior diverting procedure\n* No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment\n* No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency\n* No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine\n* No uncontrolled intercurrent illness\n* No ongoing or active infection\n* No symptomatic congestive heart failure or unstable angina pectoris\n* No cardiac arrhythmia or myocardial infarction within the past 12 months\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery)\n* No prior chemotherapy, radiotherapy, or targeted therapy for this tumor\n* More than 4 weeks since prior investigational agents\n* No concurrent anti-retroviral therapy for HIV'}, 'identificationModule': {'nctId': 'NCT00686166', 'briefTitle': 'S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer', 'orgStudyIdInfo': {'id': 'S0713'}, 'secondaryIdInfos': [{'id': 'S0713', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemo + Chemo and radiation + Surgery', 'description': 'Chemotherapy Cycle 1 (1 cycle is 35 days):\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n* Cetuximab, 400 mg/m\\^2, IV, Day 1\n* Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n* Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2:\n\n* Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78\n* Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78\n* Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)\n* Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.\n\nTherapeutic Surgical procedure: Resection', 'interventionNames': ['Biological: cetuximab', 'Drug: capecitabine', 'Drug: oxaliplatin', 'Procedure: therapeutic surgical procedure', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL', 'otherNames': ['IMG-C225', 'Erbitux', 'NSC-714692'], 'description': 'Chemotherapy cycle 1: Cetuximab, 400 mg/m\\^2, IV, Day 1; Cetuximab, 250 mg/m\\^2, IV, Days 8,15,22,29\n\nChemotherapy+ Radiation Cycle 2: Cetuximab, 250 mg/m\\^2, IV, Days 50,57,64,71,78', 'armGroupLabels': ['Chemo + Chemo and radiation + Surgery']}, {'name': 'capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda', 'NSC-712807'], 'description': 'Chemotherapy Cycle 1: Capecitabine, 1650 mg/m\\^2/day, PO, Monday-Friday (Day 1-35)\n\nChemotherapy+ Radiation Cycle 2: Capecitabine, 1650 mg/m\\^1, PO, Monday-Friday (Day 50-84)', 'armGroupLabels': ['Chemo + Chemo and radiation + Surgery']}, {'name': 'oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin', 'NSC-266046'], 'description': 'Chemotherapy Cycle 1: Oxaliplatin, 50 mg/m\\^2, IV, Days 1,8,15,22,29\n\nChemotherapy+ Radiation Cycle 2: Oxaliplatin, 50 mg/m\\^2, IV, Days 50,57,71,78', 'armGroupLabels': ['Chemo + Chemo and radiation + Surgery']}, {'name': 'therapeutic surgical procedure', 'type': 'PROCEDURE', 'otherNames': ['Resection'], 'description': 'Surgical resection', 'armGroupLabels': ['Chemo + Chemo and radiation + Surgery']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'IMRT (intensity-modulated radiation therapy)', 'armGroupLabels': ['Chemo + Chemo and radiation + Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Providence Cancer Center at Providence Hospital', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at UMC Orange Grove', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University Medical Center North', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94945', 'city': 'Novato', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health - Western Division Cancer Research Group', 'geoPoint': {'lat': 38.10742, 'lon': -122.5697}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Regional Medical Center Comprehensive Cancer Center', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center at Roseville Medical Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center - California Campus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Pacific Medical Foundation', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Solano Medical Center', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Memorial Hospital Cancer Center - Colorado Springs', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80524', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Poudre Valley Hospital', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Front Range Cancer Specialists', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Institute', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cardinal Bernardin Cancer Center at Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '62781-0001', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Regional Cancer Center at Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46107', 'city': 'Beech Grove', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Francis Hospital and Health Centers - Beech Grove Campus', 'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '47374', 'city': 'Richmond', 'state': 'Indiana', 'country': 'United States', 'facility': 'Reid Hospital & Health Care Services', 'geoPoint': {'lat': 39.82894, 'lon': -84.89024}}, {'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '66701', 'city': 'Fort Scott', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Fort Scott', 'geoPoint': {'lat': 37.83976, 'lon': -94.7083}}, {'zip': '67601', 'city': 'Hays', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hays Medical Center', 'geoPoint': {'lat': 38.87918, 'lon': -99.32677}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hutchinson Hospital Corporation', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '67301', 'city': 'Independence', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas-Independence', 'geoPoint': {'lat': 37.22424, 'lon': -95.70831}}, {'zip': '66112', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas City Cancer Centers - West', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66160-7357', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - 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