Back to resultsPhase 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)
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TS-1, oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven gastric or gastroesophageal adenocarcinoma
- ≥ D2 lymph node dissection, curative gastrectomy
- Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
- Age > 19
- ECOG 0-2
- No distant metastasis
- Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
- Written informed consent
- Possible oral intake (food, drug)
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study
- Active infection requiring antibiotics
- Pregnant, lactating women
- Concurrent systemic illness not appropriate for chemotherapy
- Resection margin (+) at permanent pathology
- Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
- Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- Paraaortic lymph node (+), pathologically proven
- women of potential childbearing not employing adequate contraception
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Arm A
Arm B
Arm C
Arm Description
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
{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
Outcomes
Primary Outcome Measures
The primary endpoint of the study is disease-free survival (DFS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01761461
Brief Title
Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
Acronym
ARTIST-II
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2013 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
547 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
{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
Intervention Type
Drug
Intervention Name(s)
TS-1, oxaliplatin
Primary Outcome Measure Information:
Title
The primary endpoint of the study is disease-free survival (DFS).
Time Frame
3-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven gastric or gastroesophageal adenocarcinoma
≥ D2 lymph node dissection, curative gastrectomy
Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
Age > 19
ECOG 0-2
No distant metastasis
Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
Written informed consent
Possible oral intake (food, drug)
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study
Active infection requiring antibiotics
Pregnant, lactating women
Concurrent systemic illness not appropriate for chemotherapy
Resection margin (+) at permanent pathology
Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
Inadequate surgery including D0, D1 resection, dissected LNs less than 12
Paraaortic lymph node (+), pathologically proven
women of potential childbearing not employing adequate contraception
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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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