Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
Conditions
Gastric Cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TS-1, oxaliplatin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Hyejin Jang, RN - 3410-6859 - hyejin1217.jang@samsung.com
Start Date
January 2013
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page