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Trial of S-1 Plus Cisplatin in Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
s-1 plus cisplatin
5-Fu plus cisplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-1 plus cisplatin

5-Fu plus cisplatin

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Time to progression

Secondary Outcome Measures

Response rate

Full Information

First Posted
September 1, 2010
Last Updated
July 22, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01198392
Brief Title
Trial of S-1 Plus Cisplatin in Gastric Cancer
Official Title
A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-1 plus cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
5-Fu plus cisplatin
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
s-1 plus cisplatin
Other Intervention Name(s)
Tegafur,Gimeracil and Oteracil Potassium Capsules
Intervention Description
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 Type
Drug
Intervention Name(s)
5-Fu plus cisplatin
Other Intervention Name(s)
5-fluoroura
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
The time from randomization until objective tumor progression or death
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guan Zhongzhen, Professor
Phone
862087343565
Email
guanzhzh@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Ruihua, Professor
Phone
862087343228
Email
xurh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUIHUA XU, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Gangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guan Zhongzhen, Professor
Phone
862087343565
Email
guanzhzh@sysucc.org.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
26439700
Citation
Li YH, Qiu MZ, Xu JM, Sun GP, Lu HS, Liu YP, Zhong MZ, Zhang HL, Yu SY, Li W, Hu XH, Wang JJ, Cheng Y, Zhou JT, Guo ZQ, Guan ZG, Xu RH. S-1 plus cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study. Oncotarget. 2015 Oct 27;6(33):35107-15. doi: 10.18632/oncotarget.5959.
Results Reference
derived

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Trial of S-1 Plus Cisplatin in Gastric Cancer

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