Spots Global Cancer Trial Database for Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
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Trial Identification
Brief Title: Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Official Title: A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Study ID: NCT02161822
Conditions
Interventions
Study Description
Brief Summary: 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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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.
Detailed Description: 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
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Samsung Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: woon ki kang, professor
Affiliation: Samsung Medical Center
Role: PRINCIPAL_INVESTIGATOR
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