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Status unknownNCT01761461ARTIST-IIUpdated Mar 25, 2020

Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial

A Phase 3 interventional study of TS-1, oxaliplatin in Gastric Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
547
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 547 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
547 participants (actual)

Study arms

  • 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

Interventions

  • DrugTS-1, oxaliplatin
06

What researchers measure

Primary outcomes

  1. The primary endpoint of the study is disease-free survival (DFS).

    Time frame: 3-year

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01761461
Lead sponsor
Samsung Medical Center
Responsible party
Won Ki Kang (Professor, Samsung Medical Center) — Principal investigator
First posted
Jan 4, 2013
Start date
Feb 6, 2013
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Mar 25, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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