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
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: s-1 plus cisplatin
Drug: 5-Fu plus cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial of S-1 Plus Cisplatin Versus 5-FU Plus Cisplatin in Patients With Unresectable or Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Time to progression [ Time Frame: The time from randomization until objective tumor progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198392

Contacts
Contact: Guan Zhongzhen, Professor 862087343565 guanzhzh@sysucc.org.cn
Contact: Xu Ruihua, Professor 862087343228 xurh@sysucc.org.cn

Locations
China, Gangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Gangdong, China, 510060
Contact: Guan Zhongzhen, Professor    862087343565    guanzhzh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: RUIHUA XU, Professor Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Zhongzhen Guan ,Ruihua Xu, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier: NCT01198392     History of Changes
Other Study ID Numbers: 2005L02859
Study First Received: September 1, 2010
Last Updated: July 22, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 22, 2014