Trial of S-1 Plus Cisplatin in Gastric Cancer

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of s-1 plus cisplatin versus 5-FU plus cisplatin as first-line therapy in the treatment of patients with advanced gastric cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Tegafur

Criteria

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 Tumours(RECIST)

• 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 treatment.

• 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 contraception.

• Patients with known active infection with HIV.

• Known hypersensitivity to any of the study drugs.