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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT01917552
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