Clinical trial · Interventional
Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
NCT01761461CI-TRIAL-00044216ARTIST-IIunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TS-1, oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
- interventionNames
- Drug: TS-1, oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
- interventionNames
- Drug: TS-1, oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm C
- description
- {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 2 cycles → S-1 40mg BID (2weeks - 1week off - 2weeks)+ RT 45 Gy (5weeks) → Rest for 4 weeks → {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 4 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.