Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT02181556
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2014-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C480833', 'term': 'IFL protocol'}, {'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karine.le-malicot@u-bourgogne.fr', 'phone': '+33 3 80 39.34.79', 'title': 'Mrs Karine Le Malicot, Head of biostatistics', 'organization': 'FFCD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to the end of treatment, on average of 8 months', 'description': 'Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)', 'eventGroups': [{'id': 'EG000', 'title': 'FOLFIRI and Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'deathsNumAffected': 25, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Colonic perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Venous TE disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Leucopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Patients Alive and Progression-free 6 Months After Inclusion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease\n\nAflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes).\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'Nb of patients alive without progression', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyse was done on all the patients included in the study (ITT)'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease\n\nAflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease'}], 'classes': [{'categories': [{'measurements': [{'value': '18.63', 'groupId': 'OG000', 'lowerLimit': '14.69', 'upperLimit': '30.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 years after the end of the treatment', 'description': "Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease\n\nAflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease'}], 'classes': [{'categories': [{'measurements': [{'value': '8.16', 'groupId': 'OG000', 'lowerLimit': '6.11', 'upperLimit': '10.38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 12 months', 'description': 'The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease\n\nAflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '41 patients were included by 9 centers between October 2014 and February 2017'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease\n\nFOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease\n\nAflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.85', 'groupId': 'BG000', 'lowerLimit': '45.72', 'upperLimit': '80.39'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-01-24', 'size': 1220755, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-03T02:23', 'hasProtocol': True}, {'date': '2018-09-14', 'size': 1075755, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-04T11:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2014-07-02', 'resultsFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-12', 'studyFirstPostDateStruct': {'date': '2014-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Patients Alive and Progression-free 6 Months After Inclusion.', 'timeFrame': '6 months', 'description': 'Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes).\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years after the end of the treatment', 'description': "Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account"}, {'measure': 'Progression-free Survival', 'timeFrame': 'up to 12 months', 'description': 'The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'Metastatic'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '32921581', 'type': 'RESULT', 'citation': 'Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.\n\nAflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.\n\nThe purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Overall state as per WHO (World Health Organization) ≤ 2\n* Life expectancy \\> 3 months\n* Metastatic adenocarcinoma of the rectum or of the colon histologically proven on the primary tumor or a metastasis\n* Unresectable metastasis (metastases) and/or inoperable patient\n* Patient eligible for a 1st line treatment associating 5 FU-Irinotecan (FOLFIRI) and aflibercept\n* At least one measurable target lesion according to RECIST criteria v1.1 not previously irradiated\n* Absence of prior treatment of the metastatic disease. Prior adjuvant chemotherapy completed at least 12 months before the metastatic cancer diagnosis is authorized\n* Satisfactory laboratory panel: Hb\\> 9 g/dl, polynuclear neutrophils \\> 1500 /mm3, platelets \\> 100,000/mm3, total bilirubin \\< 1.5 x UNL(upper normal limit), creatinine clearance \\> 50 mL/min (cockcroft-Gault formula - appendix 4), PAL (alkaline phosphatase) \\< 5 x UNL, AST (aspartate aminotransferase) and ALT (alanine aminotransferases) \\< 5 x UNL, GGT (gamma-glutamyltransferase) \\< 5 x UNL,\n* Proteinuria on urine dipstick \\< 2+. If \\> 2+ test 24-hour proteinuria, which should be \\< 1 g\n\nExclusion Criteria:\n\n* Patients whose primary tumor is in place and presenting clinical symptoms (occlusion; hemorrhage)\n* Brain metastases\n* Gilbert's syndrome\n* Uncontrolled hypercalcemia\n* Hypertension not kept under control (SBP (Systolic Blood Pressure) \\>150 mmHg and DBP (Diastolic Blood Pressure) \\>100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy\n* Any unbalanced active disease over the last 6 months: liver failure, kidney failure, respiratory failure, congestive heart failure, unstable angina, myocardial infarction, significant arrhythmia (Patients treated by anticoagulants (coumadin, warfarin) are eligible if strict monitoring of the INR( international normalized ratio) is possible)\n* Significant surgical intervention within the 28 days before the start of treatment\n* Presence of active gastroduodenal ulcer, non-healed wound or bone fracture\n* Antitumor treatments other than those included in the study (chemotherapy, targeted therapy, immunotherapy)\n* History of malignant hemopathy or cancer except for those treated more than 5 years ago and considered healed, in situ carcinomas of the uterine cervix and treated skin cancers (except for melanoma)\n* Pregnant or breast-feeding women, women of childbearing age not having taken a pregnancy test, absence of effective contraception in patients (men and/or women) of childbearing age\n* Any contraindication of the drugs used in the study\n* Impossible to meet the medical follow-up requirements of the study for geographic, social or psychological reasons"}, 'identificationModule': {'nctId': 'NCT02181556', 'briefTitle': 'Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'FFCD 1302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFIRI + Aflibercept', 'description': 'FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease', 'interventionNames': ['Drug: FOLFIRI Protocol', 'Drug: Aflibercept Injection']}], 'interventions': [{'name': 'FOLFIRI Protocol', 'type': 'DRUG', 'description': 'injection of FOLFIRI and Aflibercept every 14 days until progression of disease', 'armGroupLabels': ['FOLFIRI + Aflibercept']}, {'name': 'Aflibercept Injection', 'type': 'DRUG', 'description': 'injection of FOLFIRI and Aflibercept every 14 days until progression of disease', 'armGroupLabels': ['FOLFIRI + Aflibercept']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU - Hôtel Dieu', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU - Hôpital François Mitterand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Clinique Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Geaorge Pompidou (HEGP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital La Pitié Salpetière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Julien TAIEB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fédération Francophone de Cancérologie Digestive'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}