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Phase 3
20 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of the study is disease-free survival (DFS).

Outcome Time Frame:

3-year

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

2012-06-061

NCT ID:

NCT01761461

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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