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A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer

Phase 2
19 Years
Not Enrolling
Gastric Cancer

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Trial Information

A Phase II Study of Adjuvant S-1/Cisplatin Chemotherapy Followed by S-1-based Chemoradiotherapy in Advanced Gastric Cancer

Surgery is the only possible curative treatment of gastric cancer. However, the high
recurrence rate makes gastric cancer a disease difficult to cure by surgery alone. Despite
the benefit of CRT on local recurrence, the distant recurrence is the leading pattern of
failure. We hypothesized that gastric cancer outcome could be improved using a more
effective chemotherapy regimen. This study was conducted to evaluate the clinical outcomes
and toxicity of adjuvant treatment including S-1/cisplatin chemotherapy followed by S-1
based CRT.

Inclusion Criteria:

- Age > 18 years

- Histologically proven gastric adenocarcinoma which is complete resected

- ECOG performance status of 1 or lower

- Adequate bone marrow function

- absolute neutrophil count [ANC] ≥1,500µL, and platelets ≥100,000/µL

- Adequate kidney function (serum creatinine < 1.5 mg/dL)

- Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL)
serum transaminases levels <2 times UNL

- No prior chemotherapy

Exclusion Criteria:

- Other tumor type than adenocarcinoma

- Evidence of distant metastasis

- Past or concurrent history of neoplasm except for curatively treated non-melanoma
skin cancer or in situ carcinoma of the cervix uteri

- Uncontrolled infection

- Unstable cardiac disease despite treatment, myocardial infarction within months prior
to study entry

- History of significant neurologic or psychiatric disorders including dementia or

- Other serious underlying medical conditions which could impair the ability of the
patient to participate in the study

- Symptoms of gastrointestinal obstruction

- concomitant drug medication: The following drugs cause drug interaction with S-1.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Sang-Hee Cho, M.D.Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



Korea: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

June 2012

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • Adjuvant
  • Chemoradiotherapy
  • S-1
  • Cisplatin
  • Stomach Neoplasms