RecruitingPhase 3NCT01917552

Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG ST14-05): CATALYSIS

Phase III Study of Adjuvant Capecitabine vs Observation Alone in Curatively Resected Stage IB (by AJCC 6th Edition) Gastric Cancer(KCSG ST14-05)


Sponsor

Asan Medical Center

Enrollment

870 participants

Start Date

Aug 19, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

multi-center, prospective, randomized, open-label phase III


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing whether taking a chemotherapy drug called capecitabine (a pill) after surgery for stomach cancer helps prevent the cancer from coming back, compared to no additional treatment after surgery. **You may be eligible if...** - You have been diagnosed with stomach cancer and had surgery to remove the tumor with no detectable cancer remaining - You have fully recovered from surgery and are healthy enough for further treatment - You are at least 18 years old - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have had prior chemotherapy or radiation for this cancer before surgery - You have evidence that cancer is still present or has spread after surgery - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had a previous allergic reaction to capecitabine or similar drugs (like 5-fluorouracil) - You have another active cancer diagnosis 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

DRUGcapecitabine

capecitabine 1250 milligram (mg) / m² po bid (D1-14)


Locations(1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

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NCT01917552


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