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)

Samsung Medical Center

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: TS-1, oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01761461

2012-06-061

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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547 participants in 3 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Drug: TS-1, oxaliplatin

Arm B

Active Comparator group

Description:

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

Treatment:

Drug: TS-1, oxaliplatin

Arm C

Active Comparator group

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

Treatment:

Drug: TS-1, oxaliplatin