NIPH Clinical Trials Search

UMIN ID: C000000251

Registered date:01/11/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedGastric Cancer
Date of first enrollment2005/10/01
Target sample size628
Countries of recruitmentJapan,Asia(except Japan)
Study typeInterventional
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


Primary OutcomeTo 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 minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria1.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


public contact
Name Toshifusa Nakajima
Address 3-10-6, Ariake, Kotoku, Tokyo Japan
Telephone 03-3570-0437
Affiliation Japan Clinical Cancer Research Organization Chief Director
scientific contact
Name Masashi Fujii
Address 1-8-13, Kandasurugadai, Chiyoda-ku, Tokyo Japan
Telephone 03-3293-1711
Affiliation Surugadai Nihon University Hospital Devision of Digestive Surgery