Neo-adjuvant Simvastatin therapy in colorectal cancer

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001179-13-NL

Enrollment

Registered

2007-05-11

Start date

2008-01-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer MedDRA version: 9.1 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant

Interventions

Trade Name: Simvastatin (generic) Product Name: Simvastatin Pharmaceutical Form: Tablet INN or Proposed INN: SIMVASTATIN CAS Number: 79902639 Concentration unit: mg milligram(s) Concentration type: up

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. levels of apoptosis and proliferation in surgical resection specimens levels of angiogenesis in surgical resection specimens	—

Measure

Time frame

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. levels of apoptosis and proliferation in surgical resection specimens levels of angiogenesis in surgical resection specimens

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026