Trial of S-1 Plus Cisplatin in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198392
• Other study ID #: 2005L02859
• Status: Recruiting
• Phase: Phase 3
• First received: September 1, 2010
• Last updated: July 22, 2011
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2008
• Source: Sun Yat-sen University
• Contact: Guan Zhongzhen, Professor
• Phone: 862087343565
• Email: guanzhzh[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• s-1 plus cisplatin
S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
• 5-Fu plus cisplatin
5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Gangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		The time from randomization until objective tumor progression or death	No
Secondary	Response rate		2 months	No