Trial of S-1 Plus Cisplatin in Gastric Cancer

NCT01198392 | Unknown Phase 3 DMC

• 1 other identifier: 2005L02859
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

gastric cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  The time from randomization until objective tumor progression or death

Secondary Outcomes (1)

• Response rate

  2 months

Study Arms (2)

S-1 plus cisplatin

EXPERIMENTAL

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

5-Fu plus cisplatin

ACTIVE COMPARATOR

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

Interventions

s-1 plus cisplatin DRUG

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.

Also known as: Tegafur,Gimeracil and Oteracil Potassium Capsules

S-1 plus cisplatin

5-Fu plus cisplatin DRUG

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.

Also known as: 5-fluoroura

5-Fu plus cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gangdong, 510060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 26439700 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S-1 plus cisplatin; Tegafur; gimeracil; potassium oxonate; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• RUIHUA XU, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guan Zhongzhen, Professor

CONTACT

862087343565; guanzhzh@sysucc.org.cn

Xu Ruihua, Professor

CONTACT

862087343228; xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 25, 2011

Record last verified: 2008-08

Locations

CN (1)