Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287768
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : June 28, 2011
Korean Cancer Study Group
Information provided by:
Japan Clinical Cancer Research Organization

February 3, 2006
February 7, 2006
June 28, 2011
March 2006
September 2008   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: median ]
Median overall survival
Complete list of historical versions of study NCT00287768 on Archive Site
  • 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 ]
  • time-to-tumor progression
  • clinical response
  • safety
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Phase III Study of Docetaxel + S-1 vs. S-1 for 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).

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: docetaxel + S-1
    Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks
    Other Names:
    • taxotere
    • TS-1
  • Drug: S-1
    S-1 po days 1-28 every 6 weeks
    Other Name: TS-1
  • Experimental: 1
    Docetaxel + S-1
    Intervention: Drug: docetaxel + S-1
  • Active Comparator: 2
    Intervention: Drug: S-1

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2010
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
  • Subjects must be able to take orally
  • Measurable lesion and/or non-measurable lesion defined by RECIST
  • ECOG performance status ≦ 1
  • Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
  • Creatine ≦ upper normal limit (UNL)
  • Total bilirubin ≦ 1.5 X UNL
  • AST, ALT and ALP ≦ 2.5 x UNL
  • No prior chemotherapy
  • Life expectancy estimated than 3 months
  • Written informed consent

Exclusion Criteria:

  • Active double cancer
  • Gastrointestinal bleeding
  • Excessive amounts of ascites require drainage
  • Known brain metastases
  • Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
  • Pulmonary fibrosis, Intestinal pneumonitis
  • History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80
  • Any previous chemotherapy or radiotherapy for AGC
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
  • Treatment with any investigational product during the last 4 weeks prior to study entry
  • Definite contraindications for the use of corticosteroids
  • Any subject judged by the investigator to be unfit for any reason to participate in the study
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Masashi Fujii / Associate Professor, Department of Surgery, Surugadai Nippon University
Japan Clinical Cancer Research Organization
Korean Cancer Study Group
Principal Investigator: Masashi Fujii, MD PhD Surugadai Nihon University Hospital
Japan Clinical Cancer Research Organization
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP