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Trial of S-1 Plus Cisplatin in Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01198392
First received: September 1, 2010
Last updated: July 22, 2011
Last verified: August 2008

September 1, 2010
July 22, 2011
September 2008
December 2011   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: The time from randomization until objective tumor progression or death ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01198392 on ClinicalTrials.gov Archive Site
Response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of S-1 Plus Cisplatin in Gastric Cancer
A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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.
    Other Name: Tegafur,Gimeracil and Oteracil Potassium Capsules
  • Drug: 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.

    Other Name: 5-fluoroura
  • Experimental: 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.
    Intervention: Drug: s-1 plus cisplatin
  • Active Comparator: 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.
    Intervention: Drug: 5-Fu plus cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Guan Zhongzhen, Professor 862087343565 guanzhzh@sysucc.org.cn
Contact: Xu Ruihua, Professor 862087343228 xurh@sysucc.org.cn
China
 
NCT01198392
2005L02859
Yes
Zhongzhen Guan ,Ruihua Xu, Sun Yat-sen University Cancer Center
Sun Yat-sen University
Not Provided
Principal Investigator: RUIHUA XU, Professor Sun Yat-sen University
Sun Yat-sen University
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP