mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

Biliary Cancer Metastatic Clinical Trial

Official title:
A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03464968
Study type	Interventional
Source	Seoul National University Bundang Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	July 29, 2015
Completion date	July 25, 2020

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