Clinical trial NCT02161822: Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Official title: A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenocarcinoma of Rectum
Keywords: locally advanced rectal cancer, neoadjuvant chemoradiation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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

Eligibility criteria: 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

Primary outcomes:
measure: pathologic complete response rate
timeFrame: average of 5 weeks
Secondary outcomes:
measure: rate of sphincter-sparing surgical procedure
timeFrame: average of 5 weeks
measure: rate of R0 resection
timeFrame: average of 5 weeks
measure: disease-free survival
timeFrame: assessed up to 60 months
measure: overall survival
timeFrame: assessed up to 60 months
measure: pattern of failure
timeFrame: assessed up to 60 months
measure: safety and toxicity
timeFrame: assessed up to 6 months
measure: lipid lowering effect of simvastatin
timeFrame: assessed up to 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: woon ki kang, professor
role: PRINCIPAL_INVESTIGATOR
References: