A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-C000000251
- Lead Sponsor
- Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 628
Not provided
1.Active double cancer (except early stage colorectal cancer) 2.Gastrointestinal bleeding. 3.Excessive amounts of ascites require drainage. 4.Known brain metastases. 5.Symptomatic peripheral neuropathy ≥ grade 2. by NCI-CTCAE ver.3.0 6.Pulmonary fibrosis, Interstitial pneumonitis. 7.History of hypersensitivity to fluoropyrimidines, docetaxel, or medications formulated with polysorbate 80. 8.Any previous chemotherapy or radiotherapy for AGC. 9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. 10.Treatment with any investigational product during the last 4 weeks prior to study entry. 11.Definite contraindications for the use of corticosteroids. 12.Any subject judged by the investigator to be unfit for any reason to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare median overall survival
- Secondary Outcome Measures
Name Time Method •-To compare the time-to-tumor progression, defined as time from randomization to date of first documentation of Progressive Disease •-To compare the clinical response, according to RECIST •To evaluate the safety of the two regimens