# JASPAC 01

Source: https://onco.cc/trials/jaspac-01/  
OnCo record `jaspac-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

JASPAC 01 found that six months of the oral fluoropyrimidine S-1 after pancreatic cancer surgery nearly doubled five-year survival compared with gemcitabine in Japanese patients, 44 against 24 percent, which made S-1 the adjuvant standard in Japan; the result has never been tested in Western patients, who metabolise the drug differently.

## Summary

JASPAC 01 randomised 385 patients between April 2007 and June 2010 to gemcitabine (1,000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, up to six cycles) or S-1 (40 to 60 mg twice daily by body surface area for 28 days of a 42-day cycle, up to four cycles). The trial was designed to show non-inferiority (margin 1.25) and was stopped early in September 2012 when the interim analysis met the pre-specified criteria. With follow-up to January 2016 the hazard ratio for death was 0.57 (95 percent confidence interval 0.44 to 0.72; p below 0.0001 for both non-inferiority and superiority), with five-year overall survival 44.1 percent on S-1 against 24.4 percent on gemcitabine. Grade 3 or 4 leucopenia, neutropenia and transaminase rises were commoner with gemcitabine, stomatitis and diarrhoea with S-1. S-1 (tegafur, gimeracil and oteracil) is licensed in Europe as Teysuno for gastric and colorectal cancer only, and the authors asked for the result to be confirmed in non-Asian patients before it is adopted outside Japan; the corpus's adjuvant row cites it as the Japanese standard beside modified FOLFIRINOX and gemcitabine plus capecitabine.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: JASPAC-01; JASPAC01
- Phase: 3
- Setting: Resected stage I to III pancreatic ductal adenocarcinoma in Japan, R0 or R1: six cycles of adjuvant gemcitabine against four cycles of oral S-1 for six months, a non-inferiority trial with overall survival as the primary endpoint
- Sponsor: Japan Adjuvant Study Group of Pancreatic Cancer (Shizuoka Cancer Center), with Taiho
- Enrolled: 385
- Result: Five-year overall survival 44.1 percent with adjuvant S-1 against 24.4 percent with gemcitabine (hazard ratio 0.57, 95 percent confidence interval 0.44 to 0.72; p below 0.0001).
- Outcomes: Overall survival (per-protocol population): Adjuvant S-1 44.1% vs Adjuvant gemcitabine 24.4%, HR 0.57

## Sources

- Uesaka et al., JASPAC 01 (Lancet 2016): https://doi.org/10.1016/S0140-6736(16)30583-9
- UMIN Clinical Trials Registry UMIN000000655: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000794
- Ueno et al., GEST: S-1 non-inferior to gemcitabine in advanced disease (JCO 2013): https://doi.org/10.1200/JCO.2012.43.3680

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Tegafur, gimeracil and oteracil (S-1)](https://onco.cc/drugs/tegafur-gimeracil-oteracil/)
- companies: [Taiho Pharmaceutical (Otsuka)](https://onco.cc/companies/taiho/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [CONKO-001](https://onco.cc/trials/conko-001/), [ESPAC-4](https://onco.cc/trials/espac-4/), [PRODIGE 24 / CCTG PA6](https://onco.cc/trials/prodige-24/)

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