NCT02161822

Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients

A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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

Conditions

• Adenocarcinoma of Rectum

Interventions

Type	Name	Description
DRUG	simvastatin	simvastatin 80mg qd for 5weeks

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2014-06-12
• Last updated: 2020-03-25

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study