Randomized phase II/III trial of neoadjuvant chemotherapy with gemcitabine and S-1 versus upfront surgery for resectable pancreatic cancer (Prep-02/JSAP05)

Fuyuhiko Motoi, Tomoo Kosuge, Hideki Ueno, Hiroki Yamaue, Sohei Satoi, Masayuki Sho, Goro Honda, Ippei Matsumoto, Keita Wada, Junji Furuse, Yutaka Matsuyama, Michiaki Unno

Research output: Contribution to journalArticlepeer-review

68 Citations (Scopus)

Abstract

A randomized, controlled trial has begun to compare neoadjuvant chemotherapy using gemcitabine and S-1 with upfront surgery for patients planned resection of pancreatic cancer. Patients were enrolled after the diagnosis of resectable or borderline resectable by portal vein involvement pancreatic cancer with histological confirmation. They were randomly assigned to either neoadjuvant chemotherapy or upfront surgery. Adjuvant chemotherapy using S-1 was administered for 6 months to patients with curative resection who fully recovered within 10 weeks after surgery in both arms. The primary endpoint is overall survival; secondary endpoints include adverse events, resection rate, recurrence-free survival, residual tumor status, nodal metastases and tumor marker kinetics. The target sample size was required to be at least 163 (alpha-error 0.05; power 0.8) in both arms. A total of 360 patients were required after considering ineligible cases. This trial began in January 2013 and was registered with the UMIN Clinical Trials Registry (UMIN000009634).

Original languageEnglish
Pages (from-to)190-194
Number of pages5
JournalJapanese journal of clinical oncology
Volume49
Issue number2
DOIs
Publication statusPublished - 2019 Feb 1

Keywords

  • S-1
  • gemcitabine
  • neoadjuvant chemotherapy
  • pancreatic cancer
  • phase III

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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