Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-04 @ 5:52 PM
Study NCT ID:
NCT00623805
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2008-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
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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': {'description': 'Safety population: All participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.', 'otherNumAtRisk': 62, 'otherNumAffected': 62, 'seriousNumAtRisk': 62, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.', 'otherNumAtRisk': 61, 'otherNumAffected': 61, 'seriousNumAtRisk': 61, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hemifacial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Clinical worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased breath sounds on right lower zone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Defence, distension and rigidity in abdomen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Difficulty in breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General situational failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'H1N1 infection (influenza)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'High level of tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neutropenic fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rapid advanced dyspnea and cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rectovaginal fistule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Severe backache, shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'OG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'OG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Overall survival was defined as the time from the first administration of study drug to death.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Complete Response or a Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'OG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '59.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Time Until a Complete Response or a Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'OG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 13', 'description': 'Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'OG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a R0 Resection', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'FG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab+Capecitabine+Oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'BG001', 'title': 'Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '57.6', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population: All randomized participants with a least 1 post-randomization efficacy assessment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2008-02-18', 'resultsFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2008-02-18', 'lastUpdatePostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-16', 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Overall survival was defined as the time from the first administration of study drug to death.'}, {'measure': 'Percentage of Participants With a Complete Response or a Partial Response', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.'}, {'measure': 'Time Until a Complete Response or a Partial Response', 'timeFrame': 'Baseline to Month 13', 'description': 'Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.'}, {'measure': 'Duration of Response', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.'}, {'measure': 'Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)'}, {'measure': 'Percentage of Participants With a R0 Resection', 'timeFrame': 'Baseline to the end of the study (up to 4 years, 2 months)', 'description': 'An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m\\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\\^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, ≥ 18 years of age.\n* Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.\n* At least 1 measurable lesion.\n* Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.\n\nExclusion Criteria:\n\n* Previous treatment with Avastin.\n* Previous systemic treatment for advanced or metastatic disease.\n* clinically significant cardiovascular disease.\n* Daily chronic treatment with high doses of aspirin (\\> 325 mg/day) or non-steroidal anti-inflammatory drugs.'}, 'identificationModule': {'nctId': 'NCT00623805', 'briefTitle': 'A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'ML21440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab+capecitabine+oxaliplatin', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C', 'description': 'Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab was supplied as a solution in single-use vials.', 'armGroupLabels': ['Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C', 'Bevacizumab+capecitabine+oxaliplatin']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine was supplied as film-coated tablets.', 'armGroupLabels': ['Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C', 'Bevacizumab+capecitabine+oxaliplatin']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Oxaliplatin was supplied as a lyophilized powder in vials.', 'armGroupLabels': ['Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C', 'Bevacizumab+capecitabine+oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06500', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06590', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '27310', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '34300', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34890', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '06100', 'city': 'S?hhiye, Ankara', 'country': 'Turkey (Türkiye)', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}