Phase III Randomized Trial of Adjuvant Chemotherapy with TS-1 vs TS-1/oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003993
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 900

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, hemoglobin = 9.0g/dL, transfusion allowed)
8)Adequate renal functions(serum creatinine = 1.5mg/?)
9)liver functions (serum bilirubin = 1.5mg/?, AST/ALT = 3 times(normal value)
10)Written informed consent
11)Possible oral intake (food, drug)

Exclusion Criteria

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

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
Safety profile;Overall survival;pattern of recurrence;Planned subgroup analyses;Exploratory biomarker analysis