Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
NCT ID: NCT01761461
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
547 participants
INTERVENTIONAL
2013-02-06
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Arm A
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
TS-1, oxaliplatin
Arm B
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
TS-1, oxaliplatin
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
TS-1, oxaliplatin
Interventions
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TS-1, oxaliplatin
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Ki Kang
Professor
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2012-06-061
Identifier Type: -
Identifier Source: org_study_id
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