We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 February 2017 by Won Ki Kang, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761461
First Posted: January 4, 2013
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
  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
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Won Ki Kang, Samsung Medical Center:

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

Estimated Enrollment: 900
Actual Study Start Date: February 6, 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: January 2019 (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 (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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


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

Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01761461     History of Changes
Other Study ID Numbers: 2012-06-061
First Submitted: January 3, 2013
First Posted: January 4, 2013
Last Update Posted: February 17, 2017
Last Verified: February 2017

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