Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-06 @ 1:26 PM
Study NCT ID:
NCT01664494
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System 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'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first', 'description': 'SAEs and other AEs were collected in all enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Capecitabine', 'description': 'Participants received capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.', 'otherNumAtRisk': 563, 'otherNumAffected': 271, 'seriousNumAtRisk': 563, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Palmar-plantar erythrodysesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 172}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 117}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 110}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 63}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Enterocolitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Multiple Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Inflammatory marker increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 563, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capecitabine', 'description': 'Participants received capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.'}], 'classes': [{'title': 'Adjuvant therapy', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}]}]}, {'title': 'First line therapy', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}, {'title': 'Second line therapy', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Third line therapy', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first', 'description': 'Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were considered for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Median Dose of Capecitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capecitabine', 'description': 'Participants received capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.'}], 'classes': [{'title': 'Month 7', 'categories': [{'measurements': [{'value': '3500', 'groupId': 'OG000', 'lowerLimit': '1500', 'upperLimit': '5000'}]}]}, {'title': 'From Month 8 onwards', 'categories': [{'measurements': [{'value': '3000', 'groupId': 'OG000', 'lowerLimit': '900', 'upperLimit': '5000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first', 'description': 'Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.', 'unitOfMeasure': 'Milligrams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants were considered for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Capecitabine', 'description': 'Participants received capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}]}]}], 'recruitmentDetails': 'A total of 563 participants were included from April 2010 to July 2012 at 21 sites in Austria.', 'preAssignmentDetails': 'Of 563 participants, 220 were treated for adjuvant colon cancer, 200 were treated for metastatic colorectal cancer, 84 were treated for metastatic breast cancer, and 59 were treated for advanced gastric cancer.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Capecitabine', 'description': 'Participants received capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '11.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'The gender was not assessed in this study.', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'The gender was not assessed in this study.', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 563}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-29', 'studyFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment', 'timeFrame': 'Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first', 'description': 'Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.'}], 'secondaryOutcomes': [{'measure': 'Median Dose of Capecitabine', 'timeFrame': 'Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first', 'description': 'Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer, Colorectal Cancer, Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer receiving Xeloda', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label\n\nExclusion Criteria:\n\n* Contraindications according to label and off-label use'}, 'identificationModule': {'nctId': 'NCT01664494', 'briefTitle': 'An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-Interventional Trial of Xeloda in Metastatic Colorectal Cancer, Adjuvant Colon Cancer, Advanced Gastric Cancer and Breast Cancer', 'orgStudyIdInfo': {'id': 'ML25281'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Capecitabine', 'description': 'Participants will receive capecitabine according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine will be given according to the label text as monotherapy (1250 mg/m\\^2 twice daily) or combination therapy (800 to 1000 mg/m\\^2 or 1250 mg/m\\^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.', 'armGroupLabels': ['Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}