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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01761461
• Collaborator: (none)
• Enrollment: 547
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 93.8
• Patients Per Site Per Month: 5.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: TS-1, oxaliplatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 547 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Feb 6, 2013
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. The primary endpoint of the study is disease-free survival (DFS). [3-year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01761461
• Other Study ID Numbers: 2012-06-061
• First Posted: Jan 4, 2013
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Stomach Neoplasms; Oxaliplatin

Study Results

No Results Posted as of Mar 25, 2020