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

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.

Timeline

Start

2015-07-29

Primary completion

2020-02-10

Completion

2020-07-25

Outcome

Missed primary endpoint

paper At a median follow-up duration of 25.8 months, the 6-month OS rate was 54.1% in mFOLFOX and 44.1% in mFOLFIRI (p = 0.677). PMID 34303267 ↗

paper CONCLUSION: In the second-line treatment of BTC, mFOLFIRI was not superior to mFOLFOX. PMID 34303267 ↗

Publications

• Choi IS, Kim KH, Lee JH, Suh KJ, Kim JW, Park JH, Kim YJ, Kim JS, Kim JH, Kim JW. A randomised phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. Eur J Cancer. 2021 Sep;154:288-295. doi: 10.1016/j.ejca.2021.06.019. Epub 2021 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	150 mg/m2	—
Subject	Oxaliplatin	Small molecule	100 mg/m2	—
Background	Leucovorin	Small molecule	100 mg/m2	—
Background	fluorouracil	Small molecule	2400 mg/m2	—

Indications