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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 (ARTIST-II)

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ClinicalTrials.gov Identifier: NCT01761461
Recruitment Status : Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: TS-1, oxaliplatin Phase 3

Study Design
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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 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
 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
 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
 Drug: TS-1, oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint of the study is disease-free survival (DFS). [ Time Frame: 3-year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01761461     History of Changes
Other Study ID Numbers: 2012-06-061
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents