Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer at Stage IIIb and IV(KCSG ST15-08): TRIUMPH

NCT01935778 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-02-28

No results posted yet for this study

Summary

multicenter, open label, randomaized, phase III

The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.

Conditions

  • Gastric Cancer, Adjuvant Chemotherapy, XO

Interventions

DRUG

Docetaxel and capecitabine and oxaliplatin

Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1

DRUG

capecitabine and oxaliplatin

Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER
  • Severance Hospital

    collaborator OTHER
  • Inha University Hospital

    collaborator OTHER
  • Hallym University Medical Center

    collaborator OTHER
  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Min-Hee Ryu, M.D.,Ph.D · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-02
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01935778 on ClinicalTrials.gov