Protocol digest of randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer: Japan clinical oncology group study (JCOG1407)

Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group

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16 Scopus citations

Abstract

Gemcitabine is one of the standard treatments for locally advanced pancreatic cancer. Recent studies on metastatic pancreatic cancer have shown that combination chemotherapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) prolonged the overall survival compared with gemcitabine alone. To select the most promising chemotherapy, a randomized phase II selection design trial was started in July 2016 to compare between modified FOLFIRINOX and GnP for patients with locally advanced pancreatic cancer. A total of 124 patients will be enrolled from 36 Japanese institutions within 2.5 years. The primary endpoint is the proportion of 1-year overall survival, and secondary endpoints are progression-free survival, distant metastasis-free survival, response rate in patients with target lesions, CA19-9 response, adverse events, treatment-related death, early death, grade 4 non-hematological toxicity, and dose intensity. This trial has been registered with the UMIN Clinical Trials Registry [http://www.umin.ac.jp/ctr/index.htm], and the registration number is UMIN000023143. A randomized phase II selection design trial comparing FOLFIRINOX and GnP for patients with locally advanced pancreatic cancer started in July 2016.

Original languageEnglish
Pages (from-to)841-845
Number of pages5
JournalPancreatology
Volume18
Issue number7
DOIs
StatePublished - Oct 2018
Externally publishedYes

Keywords

  • FOLFIRINOX
  • Gemcitabine plus nab-paclitaxel
  • Locally advanced pancreatic cancer
  • Phase II selection design

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