Trial of S-1 Plus Cisplatin in Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: s-1 plus cisplatin Type: Drug
Name: 5-Fu plus cisplatin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Sun Yat-sen University Cancer Center
Guangzhou, Gangdong, China
Status: Recruiting
Contact: Guan Zhongzhen, Professor - 862087343565 - guanzhzh@sysucc.org.cn
Start Date
September 2008
Completion Date
December 2011
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page