1. Goals * The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with locally advanced or metastatic BTC as first-line therapy Secondary goals are to:evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population 2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon.22
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
1\. Treatment Schedule 1.1. Docetaxel schedule Docetaxel 35 mg/m2 is administered on day 1 and day 8 by intravenously in 100 mL of 5% dextrose solution over 30 minutes. Dexamethasone 8mg is intravenously administered before 30 minutes, and then orally 4mg every 12 hours over 48 hours. In the event of a hypersensitivity reaction, dimethidine maleate, epinephrine, and intravenous fluids will be required. 1.2. Oxaliplatin schedule Oxaliplatin 100 mg/m2 is given on day 1 by intravenous infusion in 500 mL of 5% dextrose solution over 120 minutes. Therapy will be repeated every 21 days.
Eun Ki Song
Chonbuk, South Korea
RECRUITINGResponse rate
Time frame: 2years
Treatment-related toxicities
Number and proportion of patients with adverse events according to the NCI-CTCAE (v 4.0) as a measure of treatment-related toxicities
Time frame: 2 years
Progression free survival
Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves. The median PFS and OS will be used for measure.
Time frame: 2 years
Overall survival
Both survival curves will be calculated by Kaplan-Meier method and median value will be determined according to the survival curves. The median PFS and OS will be used for measure.
Time frame: 2 years
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