Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02228668
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2014-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1636}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) up to 8 and 10 years median follow-up of the stage III population randomized in the AVANT study.', 'timeFrame': 'From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) in stage III patients at 8 years median follow-up in the subgroup of alive patients not lost to follow-up after the AVANT trial ending.', 'timeFrame': 'From randomization until 8 years median follow-up, assessed up to 3 years from the beginning of the S-AVANT study.'}, {'measure': 'Disease-Free Survival (DFS) in stage III patients at 8 and 10 years median follow-up.', 'timeFrame': 'From randomization until 10 years median follow-up, assessed up to 5 years from the beginning of the S-AVANT study.'}, {'measure': 'Relapse Free Survival (RFS) in patients with stage II and stage III colon cancer.', 'timeFrame': 'From randomization until first relapse, assessed up to 5 years from the beginning of the S-AVANT study.'}, {'measure': 'Cancer Specific Survival (CSS) in patients with stage II and stage III colon cancer.', 'timeFrame': 'From randomization until the date of death related to primary cancer or second primary colon cancer, assessed up to 5 years from the beginning of the S-AVANT study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AVANT', 'GERCOR', 'Follow up', 'Colon cancer', 'Bevacizumab', 'Overall survival'], 'conditions': ['Colon Cancer Treated With Bevacizumab After Colon Surgery']}, 'referencesModule': {'references': [{'pmid': '33074326', 'type': 'DERIVED', 'citation': 'Chibaudel B, Henriques J, Rakez M, Brenner B, Kim TW, Martinez-Villacampa M, Gallego-Plazas J, Cervantes A, Shim K, Jonker D, Guerin-Meyer V, Mineur L, Banzi C, Dewdney A, Dejthevaporn T, Bloemendal HJ, Roth A, Moehler M, Aranda E, Van Cutsem E, Tabernero J, Schmoll HJ, Hoff PM, Andre T, de Gramont A. Association of Bevacizumab Plus Oxaliplatin-Based Chemotherapy With Disease-Free Survival and Overall Survival in Patients With Stage II Colon Cancer: A Secondary Analysis of the AVANT Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020425. doi: 10.1001/jamanetworkopen.2020.20425.'}], 'seeAlsoLinks': [{'url': 'http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70509-0/abstract', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up of patients previously included in the AVANT trial from December 2004 to June 2007.\n\nClinical data of the AVANT trial will be updated. Neither additional examination nor administration of any treatment will be performed on the patients.\n\n330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium, Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece, Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).\n\nThe AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer.\n\nAdverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms.\n\nA more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.\n\nCollection of additional follow-up data will start Q3 2014. Clinical data are to be collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median follow-up (expected to be reached around Q2 2016).\n\nAll analyses will be performed on an exploratory purpose only. An analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the AVANT trial including patients lost to follow up or died).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colon cancer included in the AVANT trial and who were randomized between the three arms of treatment:\n\n* ARM A: (FOLFOX-4): Oxaliplatin, leucovorin (LV) and 5-fluorouracil (5-FU).\n* ARM B: (FOLFOX-4+bev): Bevacizumab, oxaliplatin, leucovorin (LV) and 5-fluorouracil (5-FU).\n* ARM C: (XELOX+ bev): Bevacizumab, oxaliplatin in combination with capecitabine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients randomized in the AVANT trial.\n\nExclusion Criteria:\n\n* Written opposition from alive patients'}, 'identificationModule': {'nctId': 'NCT02228668', 'briefTitle': 'Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'GERCOR - Multidisciplinary Oncology Cooperative Group'}, 'officialTitle': 'Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma', 'orgStudyIdInfo': {'id': 'S-AVANT C13-1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'GERCOR', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Aimery de Gramont, Pr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GERCOR - Multidisciplinary Oncology Cooperative Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GERCOR - Multidisciplinary Oncology Cooperative Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}