In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.
1. brief enrollment criteria * histological confirmed * refractory to first line gemcitabine plus cisplatin * fit for chemotherapy 2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks 3. randomization - stratified by tumor site and performance status
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
mFOLFOX
mFOLFIRI
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
6 months overall survival rate
at 6 months from intervention treatment, overall survival rate
Time frame: 6months
response rate
complete response, partial response
Time frame: 6months
disease control rate
complete response, partial response, stable disease
Time frame: 6months
progression free survival
from treatment start to progression or any cause of death
Time frame: 6months
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
percentage of all patients
Time frame: 6months
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