Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT00287768
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
* Subjects must be able to take orally
* Measurable lesion and/or non-measurable lesion defined by RECIST
* ECOG performance status ≦ 1
* Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
* Creatine ≦ upper normal limit (UNL)
* Total bilirubin ≦ 1.5 X UNL
* AST, ALT and ALP ≦ 2.5 x UNL
* No prior chemotherapy
* Life expectancy estimated than 3 months
* Written informed consent
Exclusion Criteria:
* Active double cancer
* Gastrointestinal bleeding
* Excessive amounts of ascites require drainage
* Known brain metastases
* Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
* Pulmonary fibrosis, Intestinal pneumonitis
* History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80
* Any previous chemotherapy or radiotherapy for AGC
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Treatment with any investigational product during the last 4 weeks prior to study entry
* Definite contraindications for the use of corticosteroids
* Any subject judged by the investigator to be unfit for any reason to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT00287768
Study Brief:
Protocol Section:
NCT00287768