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.

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: s-1 plus cisplatin; Drug: 5-Fu plus cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guan Zhongzhen, Professor; Phone Number: 862087343565; Email: guanzhzh@sysucc.org.cn
• Study Contact Backup: Name: Xu Ruihua, Professor; Phone Number: 862087343228; Email: xurh@sysucc.org.cn

Study Locations

• China
  • Gangdong
    • Guangzhou, Gangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Guan Zhongzhen, Professor; Phone Number: 862087343565; Email: guanzhzh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 5-fluoroura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to progression	The time from randomization until objective tumor progression or death

Secondary Outcome Measures

Outcome Measure	Time Frame
Response rate	2 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Ruihua Xu, Professor, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: September 1, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (ESTIMATE): September 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: gastric cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Cisplatin; Tegafur
• Other Study ID Numbers: 2005L02859