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Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01283217
Recruitment Status : Unknown
Verified June 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : January 25, 2011
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46~56% and a median survival time of 14.0~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: DS Drug: SP Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
Study Start Date : March 2010
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: DS(Docetaxel with S-1)
Docetaxel with S-1
Drug: DS
Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Other Names:
  • Test group : DS * 8 cycles
  • (S-1 70mg/m2/D, D1~14 plus Docetaxel 35 mg/m2 D1,8 q 3weeks)
Active Comparator: SP(S-1 with cisplatin)
S-1 with cisplatin
Drug: SP
S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
Other Names:
  • Control group : SP * 8 cycles
  • (S-1 70mg/m2/D, D1~14 + Cisplatin 60mg2 D1, q 3 weeks)

Primary Outcome Measures :
  1. 3-year disease free survival(DFS) [ Time Frame: 3 years ]
    Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
  • ECOG performance status 0-1
  • Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
  • D2 lymph node dissection with R0 surgery
  • Signed informed consent

Exclusion Criteria:

  • Subjects with documented distant metastasis.
  • Malabsorption syndrome or disease significantly affecting gastrointestinal function
  • Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
  • History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
  • Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy

Information from the National Library of Medicine

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): NCT01283217

Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sun-Young Rha, MD, Ph.D    82-2-2228-8050    rha7655@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01283217     History of Changes
Other Study ID Numbers: 4-2009-0708
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action