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

Samsung Medical Center1 site in 1 country547 target enrollmentFebruary 6, 2013

ConditionsGastric Cancer

InterventionsTS-1, oxaliplatin

DrugsTS-1, oxaliplatin

Overview

Phase: Phase 3
Intervention: TS-1, oxaliplatin
Conditions: Gastric Cancer
Sponsor: Samsung Medical Center
Enrollment: 547
Locations: 1
Primary Endpoint: The primary endpoint of the study is disease-free survival (DFS).
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 6, 2013

End Date

December 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Won Ki Kang

Professor

Samsung Medical Center

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)
•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

Arms & Interventions

Arm A

S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles

Intervention: TS-1, oxaliplatin

Arm B

{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles

Intervention: TS-1, oxaliplatin

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

Intervention: TS-1, oxaliplatin