In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin,efficacy of mFOLFOX/FOLFIRI vs mFOLFOX 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 arm A. mFOLFOX (Administered as a single regimen every 2weeks) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr treatment arm B. mFOLFOX/mFOLFIRI (Administered alternately every 2 weeks.) 1) mFOLFOX D1 Oxaliplatin 85mg/m2 over 2hr Leucovorin 400mg/m2 over 2hr Fluorouracil 400mg/m2 FU 2400mg/m2 over 46hr 2) mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr 3. randomization - stratified by site and performance status * Previous cancer treatment (including IO agents vs. excluding IO agents)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Administered as a single regimen every 2weeks
Administered alternately every 2weeks
Jin Won Kim
Seongnam-si, Out of US, South Korea
6months overall survival rate
at 6months 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: 6month
progression free survival
from treatment start to progression or any cause of death
Time frame: 6month
Number of participants with Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0
percentage of all patients
Time frame: 6month
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