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)

This study is currently recruiting participants.
Verified December 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01761461
First received: January 3, 2013
Last updated: December 26, 2013
Last verified: December 2013

January 3, 2013
December 26, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
The primary endpoint of the study is disease-free survival (DFS). [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01761461 on ClinicalTrials.gov Archive Site
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Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: TS-1, oxaliplatin
  • Experimental: Arm A
    S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
    Intervention: Drug: TS-1, oxaliplatin
  • Active Comparator: Arm B
    {S-1 40mg/m2 BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
    Intervention: Drug: TS-1, oxaliplatin
  • Active Comparator: Arm C
    {S-1 40mg/m2 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 40mg/m2 BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 4 cycles
    Intervention: Drug: TS-1, oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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January 2016   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Hyejin Jang, RN 3410-6859 hyejin1217.jang@samsung.com
Korea, Republic of
 
NCT01761461
2012-06-061
Yes
Won Ki Kang, Samsung Medical Center
Samsung Medical Center
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Samsung Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP