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A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer

Phase 3
18 Years
75 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer

This is a randomized, controlled, open-label,multicenter study. Patients are randomized to
one of two treatment arms : S-1 plus cisplatin and 5-FU plus cisplatin.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the stomach with inoperable locally
advanced or recurrent and/or metastatic disease.

- Male or female.

- Age 18 -75.

- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant
therapy is allowed if at least 6 months has elapsed between completion of
adjuvant/neoadjuvant therapy and enrolment into the study).

- Measurable disease, according to the Response Evaluation Criteria in Solid

- ECOG Performance status 0, 1 or 2

- Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L,
platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or,
AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or,
alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver
metastases,Creatinine clearance > 60 mL/min.

- Signed informed consent.

Exclusion Criteria:

- prior adjuvant/neoadjuvant therapy more than two regiments.

- Received any investigational drug treatment within 30 days of start of study

- Patients with active gastrointestinal bleeding.

- Neurological toxicity ≥ grade 2 NCI-CTCAE.

- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,
or basal cell carcinoma.

- History or clinical evidence of brain metastases.

- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly
controlled diabetes.

- Pregnancy women.

- Subjects with reproductive potential not willing to use an effective method of

- Patients with known active infection with HIV.

- Known hypersensitivity to any of the study drugs.

Type of Study:


Study Design:

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

Outcome Measure:

Time to progression

Outcome Time Frame:

The time from randomization until objective tumor progression or death

Safety Issue:


Principal Investigator

RUIHUA XU, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

December 2011

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • Stomach Neoplasms