This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.
This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
S-1 : The initial dosage of S-1 is determined by the body surface area: Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day Leucovorin: 25mg twice per day po. The treatment is given for one week,and no chemotherapy is given for the following one week.
leucovorin: 400mg/m2 intravenous infusion d1; 5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours repeat every 2 weeks
Jin Li'
Shanghai, Shanghai Municipality, China
RECRUITINGresponse rate
Time frame: six weeks
progression free survival
Time frame: six weeks
disease control rate
Time frame: six weeks
time to treatment failure
Time frame: six weeks
overall survival
Time frame: three months
quality of life
Time frame: six weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: six weeks
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