Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT00287768|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : June 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: docetaxel + S-1 Drug: S-1||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||628 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2010|
Docetaxel + S-1
Drug: docetaxel + S-1
Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
Active Comparator: 2
S-1 po days 1-28 every 6 weeks
Other Name: TS-1
- overall survival [ Time Frame: median ]
- time-to-progression [ Time Frame: From onset of regression to progression ]
- response rate [ Time Frame: response during observation ]
- safety [ Time Frame: side effects during observation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287768
|Principal Investigator:||Masashi Fujii, MD PhD||Surugadai Nihon University Hospital|