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CompletedNCT00182611Updated Jun 26, 2013

S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer

A Phase 3 interventional study of cisplatin and tegafur-gimeracil-oteracil potassium in Gastric Cancer, sponsored by Kyoto University. Completed at 6 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by Kyoto University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

02

Conditions studied

  • Gastric Cancer

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Keywords

  • stage III gastric cancer
  • adenocarcinoma of the stomach
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Kyoto University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 20 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine clearance ≥ 50 mL/min

Pulmonary

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

Other

  • Able to take oral medications

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for gastric cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for gastric cancer

Surgery

  • No prior surgery for gastric cancer

Other

  • No other prior therapy for gastric cancer
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
100 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Overall survival

Secondary outcomes

  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

07

Study locations

6 sites
  • Fukui Red Cross Hospital
    Fukui-shi, Fukui 918-8501, Japan
  • Kyoto University Hospital
    Kyoto, Kyoto 606-8507, Japan
  • National Hospital Organization - Kyoto Medical Center
    Kyoto, Kyoto 612-0861, Japan
  • Yamato Municipal Hospital
    Yamatotakada, Nara 635-8501, Japan
  • Kitano Hospital
    Osaka, Osaka 530-8480, Japan
  • Shimane Prefectural Central Hospital
    Izumo-shi, Shimane 693-0068, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00182611
Lead sponsor
Kyoto University
First posted
Sep 16, 2005
Start date
Apr 2004
Primary completion
Sep 2008
Completion
Nov 2008
Last update
Jun 26, 2013

Study contacts

Seiji Satoh
study chair · Kyoto University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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