Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.
1. Primary Objective: pathologic complete response rate 2. Secondary Objectives: 1. rate of sphincter-sparing surgical procedure 2. rate of R0 resection 3. disease-free survival 4. overall survival 5. pattern of failure 6. safety and toxicity 7. lipid lowering effect of simvastatin
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
simvastatin 80mg qd for 5weeks
Samsung Medical Center
Seoul, South Korea
pathologic complete response rate
pathologic complete response ratewill be shown with 95% confidence intervals
Time frame: average of 5 weeks
rate of sphincter-sparing surgical procedure
rate of sphincter-sparing surgical procedure
Time frame: average of 5 weeks
rate of R0 resection
rate of R0 resection (N-60)
Time frame: average of 5 weeks
disease-free survival
disease-free survival
Time frame: assessed up to 60 months
overall survival
Time from randomization to death or last follow-up
Time frame: assessed up to 60 months
pattern of failure
Sphincter preservation
Time frame: assessed up to 60 months
safety and toxicity
Response rate according to RECIST 1,1 guideline will also be evaluated
Time frame: assessed up to 6 months
lipid lowering effect of simvastatin
Total cholesterol, LDL-cholesterol records. (2weeks)
Time frame: assessed up to 6 months
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