A Single Arm, Phase II study of neoadjuvant chemoradiotherapy with capecitabine plus simvastatin in locally advanced rectal cancer patients

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004037
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Criteria for Inclusion:
?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:
-Hematologic : ANC ? 1500/mm3, platelet?100,000/mm3
-Hepatic : Total bilirubin < 1.5 ULN, AST/ALT <2.5 ? ULN
-Renal : Creatinine clearance ? 50 mL/min or serum creatinine < 1.5? ULN

?Written informed consent
?Willing and able to comply the protocol

Exclusion Criteria

Criteria for Exclusion:
?Prior statins therapy within 1-year from the date of study entry
?Uncontrolled or severe cardiovascular disease :
a)New York Heart Association class III or IV heart disease
b)Unstable angina or myocardial infarction within the past 6 months
c)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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival;Overall Survival;Patterns of failure;Toxicity