Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial (ARTIST-II)
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ClinicalTrials.gov Identifier: NCT01761461 |
Recruitment Status :
Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : March 25, 2020
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer | Drug: TS-1, oxaliplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 547 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Actual Study Start Date : | February 6, 2013 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
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Drug: TS-1, oxaliplatin |
Active Comparator: Arm B
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
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Drug: TS-1, oxaliplatin |
Active Comparator: Arm C
{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
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Drug: TS-1, oxaliplatin |
- The primary endpoint of the study is disease-free survival (DFS). [ Time Frame: 3-year ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven gastric or gastroesophageal adenocarcinoma
- ≥ D2 lymph node dissection, curative gastrectomy
- Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
- Age > 19
- ECOG 0-2
- No distant metastasis
- Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
- Written informed consent
- Possible oral intake (food, drug)
Exclusion Criteria:
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Subjects presenting with any of the following will not be included in the study
- Active infection requiring antibiotics
- Pregnant, lactating women
- Concurrent systemic illness not appropriate for chemotherapy
- Resection margin (+) at permanent pathology
- Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
- Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- Paraaortic lymph node (+), pathologically proven
- women of potential childbearing not employing adequate contraception

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761461
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of |
Responsible Party: | Won Ki Kang, Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT01761461 |
Other Study ID Numbers: |
2012-06-061 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | March 25, 2020 |
Last Verified: | March 2020 |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents |