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

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: TS-1, oxaliplatin

• Registration Number: NCT01761461
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Study Start: 2013-02-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 547

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm A	TS-1, oxaliplatin	S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
Arm C	TS-1, oxaliplatin	{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
Arm B	TS-1, oxaliplatin	{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is disease-free survival (DFS).	3-year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of