Gastric Cancer
Conditions
Interventions
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
Sponsors
Japan Clinical Cancer Research Organization
Korean Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 20-79 years. 2.Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma. 3.Subjects must be able to take orally. 4.Measurable lesion and/or non-measurable lesion defined by RECIST. 5.ECOG performance status ≤ 1 6.Hgb ≥ 8 g/dL, WBC 4000-12,000/mm3 platelets ≥100,000/mm3 7.Creatinine ≤ upper normal limit (UNL) 8.Total bilirubin ≤ 1.5 X UNL 9.AST (SGOT) and ALT (SGPT) ≤ 2.5 X UNL 10.Alkaline phosphastase ≤ 2.5 X UNL 11.Subjects must have fully recovered from surgical damage 12.No prior chemotherapy, however the following prior chemotherapy treatments are allowed: Prior adjuvant (or neo-adjuvant) chemotherapy: Subjects must have elapsed 6 months or more after the end of treatment, and must have fully recovered from acute toxicities of the previous treatment. 13.Life expectancy estimated more than 3 months. 14.Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare median overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| •-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 | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactToshifusa Nakajima
Japan Clinical Cancer Research Organization Chief Director
Outcome results
None listed