- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761461
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)
March 23, 2020 updated by: Won Ki Kang, Samsung Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
547
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven gastric or gastroesophageal adenocarcinoma
- ≥ D2 lymph node dissection, curative gastrectomy
- Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
- Age > 19
- ECOG 0-2
- No distant metastasis
- Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
- Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
- Written informed consent
- Possible oral intake (food, drug)
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study
- Active infection requiring antibiotics
- Pregnant, lactating women
- Concurrent systemic illness not appropriate for chemotherapy
- Resection margin (+) at permanent pathology
- Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
- Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- Paraaortic lymph node (+), pathologically proven
- women of potential childbearing not employing adequate contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Arm A
S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles
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ACTIVE_COMPARATOR: Arm B
{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint of the study is disease-free survival (DFS).
Time Frame: 3-year
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3-year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 6, 2013
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
December 1, 2020
Study Registration Dates
First Submitted
January 3, 2013
First Submitted That Met QC Criteria
January 3, 2013
First Posted (ESTIMATE)
January 4, 2013
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-06-061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
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Clinical Trials on TS-1, oxaliplatin
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-
Samsung Medical CenterCompletedColorectal NeoplasmsKorea, Republic of
-
Xijing HospitalUnknownGastrointestinal CancerChina
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Peking UniversityTaiho Pharmaceutical Co., Ltd.Unknown
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Soonchunhyang University HospitalUnknownGastric Cancer | Elderly | Oxaliplatin | S-1 | First-Line
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Min-Hee RyuCompletedGastric CancerKorea, Republic of
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Cancer Institute and Hospital, Chinese Academy...Completed
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Cancer Institute and Hospital, Chinese Academy...Unknown
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Seoul National University HospitalNational Cancer Center, Korea; Samsung Medical Center; Asan Medical Center; Seoul... and other collaboratorsCompletedBreast NeoplasmsKorea, Republic of