Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02161822
• Other study ID #: 2014-03-056
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 1, 2014
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically-confirmed adenocarcinoma of rectum

• AJCC/UICC clinical stages of cT3-4 or cN+

• age = 20 years

• ECOG performance status 0-1

• No prior chemotherapy and radiotherapy

• Adequate major organ functions as following:

• Written informed consent

• Willing and able to comply the protocol

Exclusion Criteria:

• Prior statins therapy within 1-year from the date of study entry

• Uncontrolled or severe cardiovascular disease :

New York Heart Association class III or IV heart disease Unstable angina or myocardial infarction within the past 6 months History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.

• Past or current history (within the last 5 years prior to treatment start) of other malignancies except rectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)

• Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection

• Pregnant nursing women (women of reproductive potential have to agree to use an effective contraceptive method)

• Patients with CPK > 5 X ULN at baseline

• Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Rectum
• Rectal Neoplasms

Intervention

Drug:
• simvastatin
simvastatin 80mg qd for 5weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response rate	pathologic complete response ratewill be shown with 95% confidence intervals	average of 5 weeks
Secondary	rate of sphincter-sparing surgical procedure	rate of sphincter-sparing surgical procedure	average of 5 weeks
Secondary	rate of R0 resection	rate of R0 resection (N-60)	average of 5 weeks
Secondary	disease-free survival	disease-free survival	assessed up to 60 months
Secondary	overall survival	Time from randomization to death or last follow-up	assessed up to 60 months
Secondary	pattern of failure	Sphincter preservation	assessed up to 60 months
Secondary	safety and toxicity	Response rate according to RECIST 1,1 guideline will also be evaluated	assessed up to 6 months
Secondary	lipid lowering effect of simvastatin	Total cholesterol, LDL-cholesterol records. (2weeks)	assessed up to 6 months