A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric Cancer

UMIN ID: C000000251

Registered date:01/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 2005/10/01
• Target sample size: 628
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional

Intervention(s)

Docetaxel: 40 mg/m2 (1 hour IV infusion) on Day 1 of each cycle S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 14 of each cycle (actual dose dependent upon BSA). No treatment on Days 15 through 21 of each cycle. Cycles repeated every 3 weeks
S-1: target dose of 80 mg/m2/day (orally) on Days 1 through 28 of each cycle (actual dose dependent upon BSA). No treatment on Days 29 through 42 of each cycle. Cycles repeated every 6 weeks

Outcome(s)

• Primary Outcome: To compare median overall survival
• Secondary Outcome: •-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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Japan Clinical Cancer Research Organization
• Secondary Sponsor: Korean Cancer Study Group
• Source(s) of Monetary Support: Japan Clinical Cancer Research Organization