RecruitingPhase 3NCT01935778

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

A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)

Sponsor

Asan Medical Center

Enrollment

286 participants

Start Date

Oct 2, 2013

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer, Adjuvant Chemotherapy, XO

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.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different combinations of chemotherapy drugs given after surgery to patients with stomach cancer, to find out which combination is more effective at preventing the cancer from coming back. **You may be eligible if...** - You have been diagnosed with stomach cancer and had surgery to remove the tumor - There is no detectable cancer remaining after surgery - You are in good enough health to receive chemotherapy - You are 18 to 75 years old - Your blood counts, liver, and kidney function are within normal ranges **You may NOT be eligible if...** - Cancer has spread beyond the stomach to distant organs - You have had prior chemotherapy or radiation for this cancer - You have serious heart, liver, or kidney disease - You are pregnant or breastfeeding - You have had a prior allergic reaction to any of the chemotherapy drugs being studied - You have had another cancer in the last 5 years (other than non-melanoma skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel 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

DRUGcapecitabine and oxaliplatin

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

Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT01935778