Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma
NCT ID: NCT02548195
Last Updated: 2015-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
286 participants
INTERVENTIONAL
2015-07-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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GEMOX
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.
oxaliplatin and gemcitabine
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.
Capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Interventions
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oxaliplatin and gemcitabine
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.
capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pathologically confirmed adenocarcinoma of bile duct;
* 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.
* 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
* no tumor recurrence or metastasis on baseline examination
* no history of radiotherapy or intervention therapy
Exclusion Criteria
* distant metastasis
* prothrombin time \>14s
* severe cardiopulmonary dysfunction
* severe renal dysfunction
* bone marrow suppression before the initiation of therapy
* allergic to fluorouracil, gemcitabine, or platinum
* gemcitabine was used in combination with radiotherapy
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Hui-Chuan Sun
Vice Director of the Department of Liver Surgery
Principal Investigators
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Jinpei Huang
Role: STUDY_DIRECTOR
Shanghai Zhongshan Hospital
Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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gemoxicc
Identifier Type: -
Identifier Source: org_study_id
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