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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014