NCT03464968

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Biliary Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Oxaliplatin,5FU, leucovorin	mFOLFOX
DRUG	irinotecan,5FU, leucovorin	mFOLFIRI

Timeline

• Start date: 2015-07-29
• Primary completion: 2020-02-10
• Completion: 2020-07-25
• First posted: 2018-03-14
• Last updated: 2020-12-02

Locations

1 site across 1 country: South Korea