Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
|ClinicalTrials.gov Identifier: NCT01572324|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||April 2016|
|Experimental: Arterial infusion||
Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.
- Response rates [ Time Frame: 4 months ]Describe the overall response rate with a 95% confidence interval.
- Progress free survivial [ Time Frame: 2 years ]Describe median PFS with a 95% confidence interval.
- Toxicity of HAI [ Time Frame: 1 months ]Toxicity as measured by NCI Common Toxicity Criteria
- Overall survival [ Time Frame: 3 years ]Describe median overall survival with a 95% confidence interval and estimate the overall survival rate at 12 and 24 months with 24 months with a 95% confidence interval.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572324
|Peking University Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Principal Investigator:||Xiaodong Wang, MD||Peking University Cancer hospital & Institute|