Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-04-14 @ 2:59 AM
Study NCT ID:
NCT02548195
Status:
UNKNOWN
Last Update Posted:
2015-09-14
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-11', 'studyFirstSubmitDate': '2015-08-07', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events and severe adverse events', 'timeFrame': 'from the date of first dosage to safety follow-up visit (30 days after the last dosage)', 'description': 'All toxicities will be graded by CTCAE v4'}], 'primaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': 'from the date of surgery to the date of tumor recurrence up to 36 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'from the date of surgery to the date of death up to 36 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GEMOX', 'intrahepatic cholangiocarcinoma', 'adjuvant therapy', 'oxaliplatin', 'gemcitabine', 'capecitabine', 'curative surgery'], 'conditions': ['Cholangiocarcinoma']}, 'referencesModule': {'references': [{'pmid': '22237781', 'type': 'BACKGROUND', 'citation': 'Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.'}, {'pmid': '20165987', 'type': 'RESULT', 'citation': 'Cho SY, Park SJ, Kim SH, Han SS, Kim YK, Lee KW, Lee SA, Hong EK, Lee WJ, Woo SM. Survival analysis of intrahepatic cholangiocarcinoma after resection. Ann Surg Oncol. 2010 Jul;17(7):1823-30. doi: 10.1245/s10434-010-0938-y. Epub 2010 Feb 18.'}, {'pmid': '25456367', 'type': 'RESULT', 'citation': "Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12."}, {'pmid': '8708722', 'type': 'RESULT', 'citation': 'Patt YZ, Jones DV Jr, Hoque A, Lozano R, Markowitz A, Raijman I, Lynch P, Charnsangavej C. Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol. 1996 Aug;14(8):2311-5. doi: 10.1200/JCO.1996.14.8.2311.'}, {'pmid': '15691639', 'type': 'RESULT', 'citation': 'Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403. doi: 10.1016/j.ejca.2004.10.026.'}, {'pmid': '20375404', 'type': 'RESULT', 'citation': 'Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.', 'detailedDescription': 'chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG PS≤1;\n* pathologically confirmed adenocarcinoma of bile duct;\n* R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size \\>5 cm, preoperative CA199\\>200 U/mL.\n* postoperative liver function Child Pugh Class A, leukocyte count\\>1.5\\*10\\^9/L, platelet count\\>100\\*10\\^9/L, serum alanine aminotransferase \\<1.5\\*ULN\n* no tumor recurrence or metastasis on baseline examination\n* no history of radiotherapy or intervention therapy\n\nExclusion Criteria:\n\n* hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma\n* distant metastasis\n* prothrombin time \\>14s\n* severe cardiopulmonary dysfunction\n* severe renal dysfunction\n* bone marrow suppression before the initiation of therapy\n* allergic to fluorouracil, gemcitabine, or platinum\n* gemcitabine was used in combination with radiotherapy'}, 'identificationModule': {'nctId': 'NCT02548195', 'briefTitle': 'Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma', 'orgStudyIdInfo': {'id': 'gemoxicc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEMOX', 'description': 'oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2; every three weeks for 6-8 cycles in total.', 'interventionNames': ['Drug: oxaliplatin and gemcitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine', 'description': 'capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.', 'interventionNames': ['Drug: capecitabine']}], 'interventions': [{'name': 'oxaliplatin and gemcitabine', 'type': 'DRUG', 'otherNames': ['oxaliplatin', 'gemcitabine'], 'description': 'oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.', 'armGroupLabels': ['GEMOX']}, {'name': 'capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.', 'armGroupLabels': ['Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei-Ling Li', 'role': 'CONTACT', 'email': 'livercongress@zs-hospital.sh.cn', 'phone': '+86 21 64041990'}, {'name': 'Hui-Chuan Sun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hui-Chuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'sun.huichuan@zs-hospital.sh.cn', 'phone': '+86 21 04041990', 'phoneExt': '610559'}, {'name': 'Mei-Ling Li', 'role': 'CONTACT', 'email': 'livercongress@zs-hospital.sh.cn'}], 'overallOfficials': [{'name': 'Jinpei Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of the Department of Liver Surgery', 'investigatorFullName': 'Hui-Chuan Sun', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}