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

Sponsor: Seoul National University Bundang Hospital
Study ID: NCT03464968
Phase: PHASE2
Status: Completed

Conditions

Biliary Cancer Metastatic

Eligibility Criteria

Sex: ALL
Age: 20 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Oxaliplatin,5FU, leucovorin — DRUG
mFOLFOX
irinotecan,5FU, leucovorin — DRUG
mFOLFIRI

Study Details

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.

Key Dates

Start date: Jul 29, 2015
Status verified: Dec 2020
Primary completion: Feb 10, 2020
Completion: Jul 25, 2020

Study Design

Enrollment: 120 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: mFOLFOX
D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
Experimental: mFOLFIRI
D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

Primary Outcome Measure

6 months overall survival rate [ Time Frame: 6months ]