The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks
S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks
Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks
Hallym University Sacred Heart Hospital
Anyang, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
comparison of overall survival
Time frame: upto 3years
comparison of progression-free survival
Time frame: upto 2years
comparison of response rate
Time frame: upto 2years
comparison of adverse events
Time frame: upto 2yrs
comparison of quality of life
Time frame: upto 2years
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5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks
Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 1000mg/m2 po bid)
S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr \<60ml/min, 30mg/m2 po bid)
5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
Kyungpook National University Medical Center
Daegu, South Korea
Yeongnam University Medical Center
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
...and 4 more locations