Status:
UNKNOWN
Trial of S-1 Plus Cisplatin in Gastric Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT01198392
Start Date
September 1 2008
End Date
December 1 2011
Last Update
July 25 2011
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Gangdong, China, 510060