Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 4:06 PM
Study NCT ID:
NCT00874406
Status:
UNKNOWN
Last Update Posted:
2009-04-02
First Post:
2009-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'C410216', 'term': 'Folfox protocol'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-01', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '5 years after operation'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer', 'liver metastasis', 'neoadjuvant chemotherapy'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.', 'detailedDescription': 'We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and 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\n* resectable liver metastasis\n* remnant liver volume \\>= 70%\n* without other organ metastasis or peritoneum metastasis\n* without contradiction of cardiac and pulmonary diseases\n\nExclusion Criteria:\n\n* age \\> 75 years\n* unresectable liver metastasis\n* remnant liver volume \\< 50%\n* with other organ metastasis or peritoneum metastasis\n* with contradiction of cardiac and pulmonary diseases'}, 'identificationModule': {'nctId': 'NCT00874406', 'briefTitle': 'Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer', 'orgStudyIdInfo': {'id': '2009-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.', 'interventionNames': ['Drug: tac + folfox4']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.', 'interventionNames': ['Drug: folfox4']}], 'interventions': [{'name': 'tac + folfox4', 'type': 'DRUG', 'description': 'tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4', 'armGroupLabels': ['1']}, {'name': 'folfox4', 'type': 'DRUG', 'description': 'folfox4 will be done within 28 days after liver resection', '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'}], 'overallOfficials': [{'name': 'jianmin xu, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of general surgery, zhongshan hospital, fudan university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xujianmin', 'oldOrganization': 'Zhongshan hospital, Fudan University'}}}}