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

• Status: Completed
• Trial end date: 2020-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 20 years and older

• pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater

• initially inoperable or recurrent

• ECOG 0-2

• as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)

• evaluable or measurable lesion

• within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL, neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT < UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)

• patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage

Exclusion Criteria:

• other cancer history

• pregnant or lactating

• uncontrolled medical condition such as infection or cardiovascular disease

• hypersensitivity to experimental drugs

• uncontrolled CNS metastasis, psychologic problem