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

研究成果: Article査読

114 被引用数 (Scopus)

抄録

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).

本文言語English
ページ(範囲)190-194
ページ数5
ジャーナルJapanese journal of clinical oncology
49
2
DOI
出版ステータスPublished - 2019 2 1

ASJC Scopus subject areas

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

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