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:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT01090505
Eligibility Criteria:
Inclusion Criteria:
1. DISEASE CHARACTERISTICS:
Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
3. Age:20 to 75
4. Performance status:ECOG 0-2
5. Life expectancy:Not specified
6. Hematopoietic:WBC 4,000-12,000/mm\^3；Granulocyte count ≥ 2,000/mm\^3；Platelet count ≥ 100,000/mm\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
7. Adequate organ function
8. Able to swallow oral medication
9. Written informed consent
Exclusion Criteria:
1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. Pregnant or breast-feeding women
3. Severe mental disease
4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
6. Myocardial infarction within six disease-free months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01090505
Study Brief:
Protocol Section:
NCT01090505