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S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach 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: NCT00182611
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer.

PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: cisplatin Drug: tegafur-gimeracil-oteracil potassium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 3

Detailed Description:



  • Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.


  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the curative resection rates in patients treated with these regimens.
  • Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.
  • Arm II (neoadjuvant therapy): Patients receive neoadjuvant oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression. Patients then undergo surgery and receive adjuvant S-1 as in arm I.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer
Study Start Date : April 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Progression-free survival (PFS)
  2. Postoperative PFS
  3. Surgical/pathological curative resection
  4. Death related to treatment
  5. Death related to operation
  6. Postoperative complications
  7. Adverse events

Information from the National Library of Medicine

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


  • Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction

    • Stage III disease

      • T3 or T4 and/or N2

        • No stage IV disease
    • Helical CT scan and laparoscopic staging required
  • Potentially resectable disease



  • 20 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC ≥ 4,000/mm³, but < 12,000/mm³
  • Granulocyte count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL


  • AST and ALT ≤ 2.5 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL


  • Creatinine clearance ≥ 50 mL/min


  • Arterial oxygen pressure (PaO_2) ≥ 70 mm Hg on room air


  • Able to take oral medications


Biologic therapy

  • Not specified


  • No prior chemotherapy for gastric cancer

Endocrine therapy

  • Not specified


  • No prior radiotherapy for gastric cancer


  • No prior surgery for gastric cancer


  • No other prior therapy for gastric cancer

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 identifier (NCT number): NCT00182611

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Yamato Municipal Hospital
Yamatotakada, Nara, Japan, 635-8501
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, Japan, 693-0068
Fukui Red Cross Hospital
Fukui, Japan, 918-8501
Kyoto University Hospital
Kyoto, Japan, 606-8507
National Hospital Organization - Kyoto Medical Center
Kyoto, Japan, 612-0861
Kitano Hospital
Osaka, Japan, 530-8480
Sponsors and Collaborators
Kyoto University
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Study Chair: Seiji Satoh Kyoto University

Layout table for additonal information Identifier: NCT00182611     History of Changes
Other Study ID Numbers: KYUH-UHA-GC04-03
CDR0000426403 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: November 2008

Keywords provided by National Cancer Institute (NCI):
stage III gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action