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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

Tracking Information
First Submitted Date  ICMJE February 3, 2006
First Posted Date  ICMJE February 7, 2006
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE March 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
overall survival [ Time Frame: median ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
Median overall survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
  • time-to-tumor progression
  • clinical response
  • safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
Official Title  ICMJE A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Docetaxel + S-1
    Intervention: Drug: docetaxel + S-1
  • Active Comparator: 2
    Intervention: Drug: S-1
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 3, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00287768
Other Study ID Numbers  ICMJE JACCRO GC-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masashi Fujii / Associate Professor, Department of Surgery, Surugadai Nippon University
Study Sponsor  ICMJE Japan Clinical Cancer Research Organization
Collaborators  ICMJE Korean Cancer Study Group
Investigators  ICMJE
Principal Investigator: Masashi Fujii, MD PhD Surugadai Nihon University Hospital
PRS Account Japan Clinical Cancer Research Organization
Verification Date June 2011

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