Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 4:11 PM
Study NCT ID:
NCT01677728
Status:
UNKNOWN
Last Update Posted:
2012-09-03
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-30', 'studyFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal liver metastases', 'chemotherapy', 'cetuximab', 'bevacizumab'], 'conditions': ['Colorectal Cancer', 'Liver Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore whether target therapy in combination with chemotherapy as treatment could improve survival or tumor response in patients undergoing Synchronic Hepatectomy for Colorectal Liver Metastases.', 'detailedDescription': 'In patients with colorectal cancer (CRC), the liver is the most common site of hematogenous metastases. Approximately half of patients develop hepatic metastases during the course of the disease, and hepatic metastases are responsible for death in at least two thirds of CRC patients.\n\nOver the past decade, due to the introduction of irinotecan-based or oxaliplatin-based combination chemotherapy, the median survival among patients with colorectal liver metastases (CLM) has increased from 6 \\~8 months to more than 20 months5.In recent years, target therapy has rapidly gained attention for the treatment of CLM and is under active investigation.\n\nAlthough numerous publications have reported the efficacy of target therapy in combination treatment for CLM patients, most of these studies focused solely on those patients without undergoing resection of liver metastases. In contrast, little work has concentrated on exploring the effection of target therapy for CLM patients undergoing Synchronic Hepatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From Zhongshan hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 18 - 75 years old\n* Performance status (ECOG) 0\\~1\n* colorectal adenocarcinoma pathologically\n* without any chemotherapy or radiotherapy\n* liver metastases undergoing radical resection\n* colorectal cancer undergoing radical resection\n* no other metastases\n* suitable for chemotherapy\n* agreed by patients\n\nExclusion Criteria:\n\n* age below 18 years old or greater than 75 years old\n* haven't pathological diagnosis of colorectal adenocarcinoma with liver metastase\n* with any chemotherapy or radiotherapy\n* with other metastasis\n* unresectable colorectal cancer or liver metastases\n* unsuitable for chemotherapy or target therapy\n* not agreed by patients"}, 'identificationModule': {'nctId': 'NCT01677728', 'briefTitle': 'Effect of Target Therapy on Patients Undergoing Synchronic Hepatectomy for Colorectal Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Randomized, Controlled Trial of Target Therapy Plus Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases', 'orgStudyIdInfo': {'id': 'ZSTCC'}, 'secondaryIdInfos': [{'id': 'Xjianmin', 'type': 'REGISTRY', 'domain': 'Xjianmin'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'arm A', 'description': 'patients received chemotherapy alone'}, {'label': 'arm B', 'description': 'patients received target therapy combined with chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianmin Xu, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'xujmin@yahoo.com.cn', 'phone': '86-13501984869'}, {'name': 'Jianmin Xu, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xu Jianmin, MD', 'role': 'CONTACT', 'email': 'xujmin@yahoo.com.cn', 'phone': '+86-13501984869'}], 'overallOfficials': [{'name': 'Xu Jianmin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xu jianmin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Zhongshan hospital', 'investigatorFullName': 'Xu jianmin', 'investigatorAffiliation': 'Fudan University'}}}}