Back to resultsCapecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Primary Purpose
Adenocarcinoma of Rectum
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Rectum focused on measuring locally advanced rectal cancer, neoadjuvant chemoradiation
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Simvastatin
Arm Description
single arm : Simvastatin
Outcomes
Primary Outcome Measures
pathologic complete response rate
pathologic complete response ratewill be shown with 95% confidence intervals
Secondary Outcome Measures
rate of sphincter-sparing surgical procedure
rate of sphincter-sparing surgical procedure
rate of R0 resection
rate of R0 resection (N-60)
disease-free survival
disease-free survival
overall survival
Time from randomization to death or last follow-up
pattern of failure
Sphincter preservation
safety and toxicity
Response rate according to RECIST 1,1 guideline will also be evaluated
lipid lowering effect of simvastatin
Total cholesterol, LDL-cholesterol records. (2weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161822
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
Primary Objective: pathologic complete response rate
Secondary Objectives:
rate of sphincter-sparing surgical procedure
rate of R0 resection
disease-free survival
overall survival
pattern of failure
safety and toxicity
lipid lowering effect of simvastatin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Rectum
Keywords
locally advanced rectal cancer, neoadjuvant chemoradiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
single arm : Simvastatin
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
Zocor tab
Intervention Description
simvastatin 80mg qd for 5weeks
Primary Outcome Measure Information:
Title
pathologic complete response rate
Description
pathologic complete response ratewill be shown with 95% confidence intervals
Time Frame
average of 5 weeks
Secondary Outcome Measure Information:
Title
rate of sphincter-sparing surgical procedure
Description
rate of sphincter-sparing surgical procedure
Time Frame
average of 5 weeks
Title
rate of R0 resection
Description
rate of R0 resection (N-60)
Time Frame
average of 5 weeks
Title
disease-free survival
Description
disease-free survival
Time Frame
assessed up to 60 months
Title
overall survival
Description
Time from randomization to death or last follow-up
Time Frame
assessed up to 60 months
Title
pattern of failure
Description
Sphincter preservation
Time Frame
assessed up to 60 months
Title
safety and toxicity
Description
Response rate according to RECIST 1,1 guideline will also be evaluated
Time Frame
assessed up to 6 months
Title
lipid lowering effect of simvastatin
Description
Total cholesterol, LDL-cholesterol records. (2weeks)
Time Frame
assessed up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
woon ki kang, professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
We'll reach out to this number within 24 hrs