Adenocarcinoma of Rectum Clinical Trial
Official title:
A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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
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