This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.
The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
response rate
response rate by the RECIST criteria
Time frame: 22 weeks
Grade 3-4 toxicity
toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0
Time frame: one year
median overall survival
median value of the time from enrollment to the patient's death
Time frame: 1 year
median time to treatment failure
median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity
Time frame: 1 year
resection rate
the rate of patients whose tumor was completely resected
Time frame: 1 year
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