A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent 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).
Inclusion Criteria:
Exclusion Criteria:
Chiba, Chiba 260-8670, Japan
Ehime, Ehime 791-0295, Japan
Fukuoka, Fukuoka 815-8588, Japan
Maehashi, Gunma 371-0034, Japan
Oota, Gunma 373-8550, Japan
Hiroshima, Hiroshima 734-8553, Japan
Nishimiya, Hyōgo 663-8501, Japan
Kagoshima, Kagoshima-ken 890-8520, Japan
Yokohama, Kanagawa 241-0811, Japan
Oomura, Nagasaki 856-8562, Japan
Chutougun, Okinawa 903-0215, Japan
Kimen, Osaka 562-8562, Japan
Shimono, Tochigi 329-0498, Japan
Shimotsuga, Tochigi 321-0293, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Chiyoda-ku, Tokyo 101-8309, Japan
Itabashi-ku, Tokyo 173-8606, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Koto-ku, Tokyo 135-8550, Japan
Koto-ku, Tokyo 135-8550, Japan
Koto-ku, Tokyo 135-8577, Japan
Meguro-ku, Tokyo 152-0021, Japan
Meguro-ku, Tokyo 153-8515, Japan
Minato-ku, Tokyo 105-8470, Japan
Minato-ku, Tokyo 105-8471, Japan
Minato-ku, Tokyo 108-8329, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Shinjuku-ku, Tokyo 162-8655, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Kohfu, Yamanashi 400-8506, Japan