S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.
* Endpoints: * Primary endpoints: adverse drug reaction * Secondary endpoints: * Overall Response Rate:ORR * Progress Free Survival: PFS * Time to Treatment Failure:TTF
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
S-1(20mg、25mg), capsule, 40\~60mg, Bid,p.o., day1\~7; LV (25 mg), tablet, 25mg,Bid,p.o., day1\~7; L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: from first administration till 28 days after last dosage
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)
Time frame: every 6 weeks
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