multi-center, prospective, randomized, open-label phase III
This is a prospective, randomized, open-label phase III study of adjuvant chemotherapy after curative resection in patients with pathologic stage IB (by AJCC 6th edition) gastric cancer with at least one additional risk factor (additional risk factors for recurrence include age \>65 years, male gender, presence of lymphovascular invasion, presence of perineural invasion). The superiority design will compare the efficacy and safety profiles of adjuvant capecitabine (Arm A) versus observation alone (Arm B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
870
capecitabine 1250 milligram (mg) / m² po bid (D1-14)
Asan Medical Center
Seoul, Songpa-gu, South Korea
RECRUITINGrecurrence-free survival
To demonstrate that capecitabine is superior to observation only (control arm) in terms of recurrence-free survival in curatively resected stage IB gastric cancer.
Time frame: 8 years
overall survival
To compare overall survival in the capecitabine arm compared with the control arm.
Time frame: 8 years
Safety profiles
Toxicity profiles will be assessed with the patient 28 +/- 3 days after the last intake of study medication is required. (treatment arm only)
Time frame: 8years
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