Gastric Cancer
Conditions
Brief summary
The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.
Interventions
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is disease-free survival (DFS). | 3-year |
Countries
South Korea
Outcome results
None listed