Trial Information

A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer

Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per
year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of
subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for
subjects with AGC.

S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT)
and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium
oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late
90'in Japan. Phase II trials have demonstrated that S-1 is active, as a single agent, for
the treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small
cell lung, and pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing
5-FU alone and CPT-11/CDDP combination are currently underway and these results are awaited.
Despite of JCOG 9912 study is ongoing, 80% of patients of AGC are already treated by S-1,
because of high RR and convenience use for out-patient basis. P-II studies S-1/CDDP,
S-1/CPT-11 and S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore,
P-III studies are already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The
aim of this study is to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This
study is a prospective, multicenter, multinational, non-blinded, randomized phase III study.

Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing
before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will
be considered for enrollment into study. Then patients will be randomly assigned into two
groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).