A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, Gyeonggido, South Korea
Kyung Pook National University Hospital
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR.
Time frame: Up to 2 years
Number of Patients With Adverse Events
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years
Time frame: Up to 2 years
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Seoul Samsung Medical Center
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Ulsan University Hospital
Ulsan, South Korea