eo-adjuvant Simvastatin therapy in colorectal cancer

• Conditions: Colorectal cancer; MedDRA version: 9.1Level: HLTClassification code 10010023Term: Colorectal neoplasms malignant

• Registration Number: EUCTR2007-001179-13-NL
• Lead Sponsor: Dutch Cancer Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age > 18 years
Histologically proven adenocarcinoma of the colorectum
Eligible for surgical resection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

use of, or hypersensitivity to, HMGCoA reductase inhibitors (statins)
use of other lipid lowering drugs (e.g. Fibrates)
use of NSAIDs
Patients requiring radiotherapy, chemotherapy or endoscopic stent therapy during the treatment period and thus prior to surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To ascertain whether orally delivered Simvastatin affects levels of apoptosis, proliferation and bone morphogenetic protein pathway activation in colorectal cancer in humans.;Secondary Objective: ;Primary end point(s): Levels of BMP2 and 4 and phospho-Smad1 in surgical resection specimens.<br>levels of apoptosis and proliferation in surgical resection specimens<br>levels of angiogenesis in surgical resection specimens