Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT00868569
Status:
UNKNOWN
Last Update Posted:
2009-03-25
First Post:
2009-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-24', 'studyFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years after operation'}], 'secondaryOutcomes': [{'measure': 'resection rate of liver metastasis progression-free survival', 'timeFrame': '5 years after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver metastasis', 'colorectal cancer', 'oxaliplatine', 'transartery chemotherapy', 'embolision', 'Unresectable Liver Metastasis of Colorectal Cancer'], 'conditions': ['Liver Metastasis', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.', 'detailedDescription': 'We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, overall survival as evaluated by intent-to-treat analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\< 75 years with histologically proven adenocarcinoma of the colon or rectum\n* no severe major organ dysfunction\n* WHO performance status of 0 or 1\n* no prior cancer therapy\n* with measurable unresectableliver metastasis\n* without other metastasis\n\nExclusion Criteria:\n\n* age \\>= 75\n* severe major organ dysfunction\n* WHO performance status of \\>1\n* prior cancer therapy\n* with other metastasis'}, 'identificationModule': {'nctId': 'NCT00868569', 'briefTitle': 'Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial', 'orgStudyIdInfo': {'id': '2009-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.', 'interventionNames': ['Procedure: TACE + folfox 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy (TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.', 'interventionNames': ['Procedure: TAC + folfox4']}], 'interventions': [{'name': 'TACE + folfox 4', 'type': 'PROCEDURE', 'description': 'tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml\n\nfolfox4', 'armGroupLabels': ['1']}, {'name': 'TAC + folfox4', 'type': 'PROCEDURE', 'description': 'tac: oxaliplatin 100mg + fudr 1g + mmc 10mg\n\nfolfox4', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianmin xu, MD, PHD', 'role': 'CONTACT', 'email': 'xujmin@yahoo.com.cn', 'phone': '008613501984869'}, {'name': 'jianmin xu, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'jianmin xu, MD, PHD', 'role': 'CONTACT', 'email': 'xujmin@yahoo.com.cn', 'phone': '008613501984869'}, {'name': 'yunshi zhong, MD', 'role': 'CONTACT', 'email': 'zhongamy2002@126.com', 'phone': '008613564623481'}], 'overallOfficials': [{'name': 'jianmin xu, MD, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'department of general surgery, zhongshan hospital, fudan university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xujianmin', 'oldOrganization': 'Zhongshan hospital, Fudan University'}}}}