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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)

This study is currently recruiting participants.
Verified January 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: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention Phase
Gastric Cancer
 Drug: TS-1, oxaliplatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The primary endpoint of the study is disease-free survival (DFS). [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (4weeks - 2weeks off) x 1 cycles → S-1 40mg BID (2weeks - 1week off - 2weeks) + RT 45 Gy (5weeks) → Rest for 4 weeks → S-1 40-60mg BID (4weeks - 2weeks off) x 6 cycles
 Drug: TS-1, oxaliplatin
Active Comparator: Arm C
S-1 40mg/m2 BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
 Drug: TS-1, oxaliplatin
Active Comparator: Arm D
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
 Drug: TS-1, oxaliplatin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761461

Contacts
Contact: Hyejin Jang, RN 3410-6859 hyejin1217.jang@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Jang, RN     3410-6859     hyejin1217.jang@samsung.com    
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01761461     History of Changes
Other Study ID Numbers: 2012-06-061
Study First Received: January 3, 2013
Last Updated: January 3, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013