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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT01761461
Eligibility Criteria:
Inclusion Criteria:
1. Histologically proven gastric or gastroesophageal adenocarcinoma
2. ≥ D2 lymph node dissection, curative gastrectomy
3. Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
4. Age \> 19
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent
11. Possible oral intake (food, drug)
Exclusion Criteria:
* Subjects presenting with any of the following will not be included in the study
1. Active infection requiring antibiotics
2. Pregnant, lactating women
3. Concurrent systemic illness not appropriate for chemotherapy
4. Resection margin (+) at permanent pathology
5. Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
6. Inadequate surgery including D0, D1 resection, dissected LNs less than 12
7. Paraaortic lymph node (+), pathologically proven
8. women of potential childbearing not employing adequate contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01761461
Study Brief:
Protocol Section:
NCT01761461