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

NCT01761461 | Unknown Phase 3 DMC

• 1 other identifier: 2012-06-061
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is disease-free survival (DFS).

  3-year

Study Arms (3)

Arm A

EXPERIMENTAL

S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles

Drug: TS-1, oxaliplatin

Arm B

ACTIVE COMPARATOR

{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles

Drug: TS-1, oxaliplatin

Arm C

ACTIVE COMPARATOR

{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

Interventions

TS-1, oxaliplatin DRUG

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

titanium silicide; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 4, 2013
• Study Start: February 6, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

KR (1)