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Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

Phase 2
18 Years
70 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer

This controlled study is designed to evaluate the efficacy of S-1 on survival compared with
S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by
treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days
after curative resection. To assess the efficacy, data on recurrence and survival will be
collected from the time of enrollment until 5 years after surgery. To evaluate safety, data
on adverse events will be collected from the time of enrollment until 1 year after surgery.

Inclusion Criteria:

1. 18-70 years

2. Histologically proven adenocarcinoma of the stomach

3. Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to
either study arm within 6 weeks after surgery

4. Stage II, III and IV (M0)(AJCC 7th edition)

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

6. No prior chemotherapy or radiotherapy

7. Adequate bone marrow, renal, and liver function

Exclusion Criteria:

1. Pregnant or lactating women.

2. Women of childbearing potential with either a positive or no pregnancy test at
baseline. Postmenopausal women must have been amenorrheic for at least 12 months to
be considered of non-child bearing potential.

3. Sexually active males and females (of childbearing potential) unwilling to practice
contraception during the study.

4. Any evidence of metastatic disease (including presence of tumor cells in the

5. Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except
corticosteroids, for the currently treated gastric cancer.

6. Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from the effects of major surgery.

7. History of another malignancy within the last five years except cured basal cell
carcinoma of skin and cured carcinoma in-situ of uterine cervix.

Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery
disease, New York Heart Association (NYHA) grade II or greater congestive heart
failure or serious cardiac arrhythmia requiring medication or myocardial infarction
within the last 12 months.

8. Lack of physical integrity of the upper gastrointestinal tract or those who have
malabsorption syndrome likely to influence absorption of capecitabine, or inability
to take oral medication.

9. Organ allografts requiring immunosuppressive therapy.

10. Serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease.

11. Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without
documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known
DPD deficiency.

Hypersensitivity to platinum compounds or any of the components of the study

12. Received any investigational drug or agent/procedure, i.e. participation in another
trial, within 4 weeks before randomization.

13. Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior
to study treatment start.

14. Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
chemically related analogues, such as brivudine.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Outcome Description:

RFS was defined as the time from the date of surgery to relapse or death from any cause.

Outcome Time Frame:

3 years from enrollment.

Safety Issue:


Principal Investigator

Wansik Yu, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kyungpook National University


Korea: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

September 2016

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • S-1
  • cisplatin
  • adjuvant chemotherapy
  • Stomach Neoplasms