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NCT01761461 Clinical 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

Gastric Cancer Clinical Trial

— ARTIST-II  

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01761461
Other study ID # 2012-06-061
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 6, 2013
Est. completion date December 2020

Study information
Verified date March 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 547
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TS-1, oxaliplatin

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint of the study is disease-free survival (DFS). 3-year
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