Format

Send to

Choose Destination
Jpn J Clin Oncol. 2019 Feb 1;49(2):190-194. doi: 10.1093/jjco/hyy190.

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

Author information

1
Department of Surgery, Tohoku University School of Medicine, Sendai, Japan.
2
Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
3
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
4
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
5
Department of Surgery, Kansai Medical University, Osaka, Japan.
6
Department of Surgery, Nara Medical University, Nara, Japan.
7
Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
8
Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
9
Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
10
Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.
11
Department of Biostatistics, School of Public Health, University of Tokyo, Tokyo, Japan.

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).

PMID:
30608598
DOI:
10.1093/jjco/hyy190
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center